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Metformin Hydrochloride Extended-Release Tablet - recalled due to Due to detection of N-Nitrosodimethylamine (NDMA), USA

June 5, 2020 4:00 PM

United States

Metformin Hydrochloride Extended-Release Tablet - recalled due to Due to detection of N-Nitrosodimethylamine (NDMA), USA

Company name: Teva Pharmaceuticals USA Inc.
Brand name: Actavis
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 05, 2020
Recall details: Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.

- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

- NDC: 62037-571-01/ Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1329548A/ Expiration: 06/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1338302M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348968M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348969M/ Expiration: 11/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348970M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1376339M/ Expiration: 09/2021

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1323460M/ Expiration: 06/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1330919M/ Expiration: 06/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1338300A/ Expiration: 10/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1341135M/ Expiration: 12/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1391828M/ Expiration: 11/2021

- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333338M/ Expiration: 08/2020

- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333339A/ Expiration: 08/2020

- NDC: 62037-577-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count/ Lot Number: 1354471A/ Expiration: 02/2021

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Drugs
United States

Related Reports

July 8, 2020 12:00 PM

“Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg
Reason of the recall: N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: July 08, 2020
Recall details: Lupin Pharmaceuticals Inc. is voluntarily ... See Morerecalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Metformin Hydrochloride Extended-Release Tablets USP is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg is packaged in 60, 90 and 100 count bottles and was distributed nationwide in the US to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets. The recalled NDC’s are included in the table below:

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-338-01 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-339-09 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-336-07 / Distribution Dates: 11/05/2018 - 05/22/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-337-07 / Distribution Dates: 11/05/2018 - 05/22/2020

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chain, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product NDC’s.

Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 1000mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 7, 2020 3:00 PM

“Company name: Mylan Institutional LLC
Brand name: Mylan
Product recalled: Daptomycin for Injection
Reason of the recall: Presence of particulate matter
FDA Recall date: July 07, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is ... See Moreconducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall.

Intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. This batch was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020. The recalled batch is as follows:

- NDC #: 67457-813-50
- Material Description: Daptomycin for Injection
- Strength: 500 mg/vial
- Size: 20 mL vial
- Lot No: 7605112
- Expiry: October 2021

Daptomycin for injection is an injectable antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia) in adult patients.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop use/further distribution or dispensing.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

July 6, 2020 4:00 PM

“Company name: Baxter International Inc.
Brand name: Granules
Product recalled: Metformin Hydrochloride Extended-Release Tablets USP, 750 mg
Reason of the recall: N-Nitrosodimethylamine (NDMA)
FDA Recall date: July 06, 2020
Recall details: Company Announcement Granules Pharmaceuticals, Inc., Cha ... See Morentilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit. Granules’ test results showed NDMA levels above the FDA acceptable limit in one (1) out of the twelve (12) batches distributed to the US market. All other batches continue to remain within the specifications. Out of abundance of caution Granules Pharmaceuticals, Inc. has decided to voluntarily recall all twelve (12) of the distributed lots within expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market. Granules Pharmaceuticals, Inc. has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter. Granules Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg & 1000 mg and Metformin Hydrochloride Extended-Release Tablets USP, 500 mg are not affected by this recall. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The Metformin Hydrochloride Extended-Release Tablets USP, 750 mg lots subject to the recall is identified in the table below. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

July 6, 2020 3:00 PM

“Company name: ITECH 361
Brand name: All Clean
Product recalled: Hand sanitizer
Reason of the recall: Potential presence of methanol (wood alcohol).
FDA Recall date: July 06, 2020
Recall details: Company Announcement ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, ... See MoreMoisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning To date ITECH 361 has not received reports of adverse events related to this recall. The product is used as a hand sanitizer and moisturizer and is packaged in one (1) liter plastic bottles with UPC Code 628055370130. All Clean Hand Sanitizer and Moisturizer was distributed Nationwide to wholesale distributors and retailers. ITECH 361 is notifying its distributors by a Notice of a voluntary recall and consumers via this press release. ITECH 361 is arranging for return/replacement or refund of all recalled products. Consumers/distributors/retailers that have the product subject to this recall should stop using All Clean Hand Sanitizer, Moisturizer and Disinfectant and return it to the place of purchase. Consumers with questions regarding this recall can contact Corina Enriquez by phone number (888)405-4442 or e-mail at corina@itech361.com, Monday through Friday beginning July 6, 9:00a.m. to 5:00 p.m. (MDT). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

June 29, 2020 2:01 PM

“Company name: UVT, INC.
Brand name: Saniderm
Product recalled: Advanced Hand Sanitizer, 70% alcohol content
Reason of the recall: Potential presence of methanol (wood alcohol)
FDA Recall date: June 29, 2020
Recall details: UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED H ... See MoreAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) To date, UVT, INC. has not received any reports of adverse events related to this recall.

The affected SANIDERM ADVANCED HAND SANITIZER includes lot number 0530, Expiration date 04/2022. The product can be identified by the label below. The product was distributed Nationwide in the United States. The product is used as a hand sanitizer and is packaged in 1-liter plastic bottles.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

UVT, INC. is notifying its distributors and customers by phone calls, emails and letter and is arranging for replacement and destruction of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using products, initiate recalls to the user level, and return all products to the place of purchase.

Consumers with questions regarding this recall can contact UVT, INC. by phone (951) 427- 3108 or e-mail to customerservice@uvt.world Monday to Friday from 9:00 am and 3:00 pm Pacific Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

June 27, 2020 10:00 AM

“Company name: Saniderm Products
Brand name: Saniderm
Product recalled: Advanced Hand Sanitizer
Reason of the recall: May contain methanol (wood alcohol)
FDA Recall date: June 27, 2020
Recall details: Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packag ... See Moreed in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). To date, Saniderm has not received any reports of adverse events related to the product in question.

In response to a recent news alert by the Food and Drug Administration advising consumers of potentially toxic hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, Saniderm has proactively taken necessary precautions to ensure the safety of consumers. Out of an abundance of caution, Saniderm has initiated a voluntary recall of all products produced by Eskbiochem SA de CV with a “Made in Mexico” origin.

The product is a hand sanitizer and is packaged in 1-liter plastic bottles with an orange twist-top cap. The affected Sandiderm Advanced Hand Sanitizer include lot number 53131626, manufactured date April/1/20, clear bottle that can be further distinguished by looking at the back side label and identifying “Made in Mexico” and “Produced by: Eskbiochem SA de CV”. No other bottles distributed by Saniderm match the description above, hence all products as described above are subject to the voluntary recall. The product can be identified by the photos below. The product was distributed in Virginia, Maryland, and New Jersey on April 15,2020.

Risk Statement: Substantial methanol exposure “could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.”

Saniderm is notifying its distributors and customers by email and is arranging for the handling of all voluntary recalled products. All individuals that have the bottle in question should immediately stop using and contact Saniderm for guidance on the return and disposal of the product. Consumers with questions regarding this voluntary recall can contact Saniderm at +1 (415) 562-5502‬ or info@sanidermproducts.com from Monday-Friday 9am-6pm, PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

June 23, 2020 8:01 PM

“Company name: Golden Nutrition Inc.
Brand name: Golden Nutrition Inc.
Product recalled: Anti-Viral Immune Enhancement Capsules
Reason of the recall: Unsubstantiated Health Claims on Label
FDA Recall date: June 23, 2020
Recall details: Golden Nutrition Inc. of Opa Locka, Florida is recalling fou ... See Morer (4) Lots of Anti-Viral Immune Enhancement Capsules because the label makes unsubstantiated health claims. The recalled Anti-Viral Immune Enhancement were distributed to distributors through orders. The distribution is in Puerto Rico where consumers are able to get the product via retailers.

The product of 60 capsules comes in a green 150cc PET Bottle, with a gold cap marked with lot and expiration number on the bottom of the bottle. The Lot and expiration numbers that are being recalled are the following: Lot:1493 with Expiration: 04/2023, Lot:1499 with Expiration: 04/2023, Lot:1513 with Expiration:05/2023, and Lot:1515 with Expiration 05/2023.  

No illnesses have been reported to date in connection with this problem.

The noncompliance with FDA regulations for label claims was noted after one of our distributors brought it to our attention. The label makes unsubstantiated health claims that the product “helps fight corona virus and influenza.” Consumers that use this product instead of seeking medical treatment run the risk of serious, life threatening health consequences. The production of the product has been suspended while the company works to correct the label. Consumers who have purchased the Anti-Viral Immune Enhancement are urged to return them to the place of purchase for a full refund.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

June 18, 2020 11:00 PM

“Company name: GSK Consumer Healthcare
Brand name: Robitussin
Product recalled: Cough and cold products
Reason of the recall: Incorrect dosing cups
FDA Recall date: June 18, 2020
Recall details: GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Ch ... See Moreildren's Robitussin® Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children's Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children's Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use). Children's Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children's Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults.

Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behaviour; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention.

As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product. The recall is limited to the three lots listed below:

Children's Robitussin® Honey Cough and Chest Congestion DM (4oz)
NDC 0031-8760-12
Lots: 02177 (Exp. Jan. 2022) / 02178 (Exp. Jan. 2022)

Children's Dimetapp® Cold and Cough (8oz)
NDC 0031-2234-19
Lot: CL8292 (Exp. Sep. 2021)

These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately.

Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. In December 2018, GlaxoSmithKline plc reached an agreement with Pfizer, Inc. to combine their consumer health businesses into a new Joint Venture. August 01, 2019 was the first day of the new GSK Consumer Healthcare Joint Venture. Thus, when identifying impacted product, please be aware the Pfizer company name will still be present on the label.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

June 11, 2020 1:00 PM

“Company name: Lupin Pharmaceuticals, Inc
Brand name: Lupin
Product recalled: Metformin Hydrochloride Extended-release Tablets
Reason of the recall: Detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 11, 2020
Recall details: Lupin Pharmaceuticals Inc. is voluntarily recalling Met ... See Moreformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Metformin Hydrochloride Extended-Release Tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in a bottle containing 60 tablets with NDC 68180-336-07. The affected lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg is included in below table:

- Product Name: Metformin Hydrochloride Extended-Release Tablets USP, 500mg

- NDC: 68180-336-07

- Lot Number: G901203

- Expiration Date: 12/2020

The product can be identified by the NDC and the lot number available on the side of the bottle label. Metformin Hydrochloride Extended-Release Tablets USP, 500mg was distributed nationwide in the USA to wholesalers, distributors, and mail order pharmacies.

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

June 5, 2020 5:00 PM

“Company name: Marksans Pharma Limited, India
Brand name: Time-Cap Labs, Inc.
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 05, 2020
Recall details: Marksans Pharma Limi ... See Moreted, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.

Marksans Pharma Limited has not received any reports of adverse events related to this recall to date. Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side.

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg
Lot #: XP9004
Expiry Date (MM/YYYY): 12/2020

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. nationwide in the USA to wholesalers who further distributed to pharmacies. Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lot.

Distributors/retailers that have Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 which is being recalled should return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Recent Interesting Reports

July 6, 2020 3:00 PM

“Company name: ITECH 361
Brand name: All Clean
Product recalled: Hand sanitizer
Reason of the recall: Potential presence of methanol (wood alcohol).
FDA Recall date: July 06, 2020
Recall details: Company Announcement ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, ... See MoreMoisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning To date ITECH 361 has not received reports of adverse events related to this recall. The product is used as a hand sanitizer and moisturizer and is packaged in one (1) liter plastic bottles with UPC Code 628055370130. All Clean Hand Sanitizer and Moisturizer was distributed Nationwide to wholesale distributors and retailers. ITECH 361 is notifying its distributors by a Notice of a voluntary recall and consumers via this press release. ITECH 361 is arranging for return/replacement or refund of all recalled products. Consumers/distributors/retailers that have the product subject to this recall should stop using All Clean Hand Sanitizer, Moisturizer and Disinfectant and return it to the place of purchase. Consumers with questions regarding this recall can contact Corina Enriquez by phone number (888)405-4442 or e-mail at corina@itech361.com, Monday through Friday beginning July 6, 9:00a.m. to 5:00 p.m. (MDT). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

June 24, 2020 6:00 PM

“Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
Product recalled: Colored contact lenses
Reason of the recall: Distributed without FDA clearance may pose health risk
FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiate ... See Mored a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. The company has received no complaints to date.

These colored contact lenses were sold through the company website and shipped directly to the customer from 08/05/2019 - 10/11/2019. The recalled products were manufactured in August 2018 and may be identified by name of the product and the date of manufacture, “2018-08”, found on the package label. The following products are being recalled:

- TTDeye. Black Starshine. Lot code: B16112100
- TTDeye. Diamonds Starlight. Lot code: B16112203
- TTDeye. Flower. Lot code: Brown. Lot code: B16112210
- TTDeye. Flower Grey. Lot code: B16112231
- TTDeye. Radial. Lot code: Brown. Lot code: B16112109
- TTDeye. Radial Pink. Lot code: B16112110
- TTDeye. Devil Red. Lot code: B16112201

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.com between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

Chengdu Ai Qin E-commerce Co., Ltd is notifying its customers by email and is arranging for return/replacement of all recalled colored contact lenses.

Chengdu Ai Qin E-commerce Co., Ltd is voluntarily recalling these contact lenses after becoming aware of the problem. Chengdu Ai Qin E-commerce Co., Ltd has notified the FDA of this action.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

June 22, 2020 11:32 AM

“⁩ bought from this branch and in date to the 24th! Slices are slimy before finding it in really badly undercooked inside! Having suffered with E. coli a few years ago I am not prepared to go through that again 🤷‍♀️🤷‍♀️ See Less
Reported By SafelyHQ.com User

February 23, 2020 4:39 AM

“guy having flu, not wearing a mask and still working and serving. in this covid season, i dont really know understand why employee was sick was allowed to work without wearing mask even if not covid season, it is basis hygenic issue 101 to wear a mask if you are having flu. so when i highlight the i ... See Moressue the on.duty manager. she made me waited 30mins and doesnt realy care about it instead she just asked me talk to her supeior on the phone which made me.waited another 30mins. Her superior doesnt even concern at all. some.more there is no.hand sanitizer at the.cashier. If this is the health standard i will boycott them and support local barister instear. See Less
Reported By SafelyHQ.com User

April 20, 2020 4:00 PM

“Company name: Fresenius Kabi USA, LLC
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL
Reason of the recall: Presence of Particulate Matter
FDA Recall date: April 20, 2020
Recall details: Freseni ... See Moreus Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen, and polyamides.

Particulate matter was found in eight reserve sample vials. Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days. Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

- Ketorolac Tromethamine Injection, USP, 30 mg / mL, 1 mL fill in a 2 mL amber vial. NDC: 63323-162-01. Product code: 160201. (Check the recall notice for specific batch numbers)
- Ketorolac Tromethamine Injection, USP, 60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial. NDC: 63323-162-02. Product code: 160202. (Check the recall notice for specific batch numbers)

Check the full recalled product list and details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 29, 2020 8:00 PM

“Company name: PGG/HSC Feed Company, LLC, dba CHS Nutrition
Brand name: CHS Inc.
Product recalled: Champion Meat Goat Pellets R20, Medicated Feed
Reason of the recall: Due to elevated level of Rumensin ... See More(monensin)
FDA Recall date: May 29, 2020
Recall details: PGG/HSC Feed Company, LLC, dba CHS Nutrition of Hermiston, Oregon, is recalling 510 bags (50 lbs. each) of Champion Meat Goat Pellets R20, Medicated Feed due to elevated level of Rumensin (monensin). Monensin is an FDA-approved drug for use in certain animal feeds. However, if the feed contains excessive amounts, the feed can cause monensin toxicity in a number of animal species including goats. Goats ingesting excessive levels of monensin in feed are susceptible to injury and death. In goats, signs and symptoms can include bloated stomach, bloody urine, shortness of breath, muscle weakness or cramps, rapid breathing and death. In humans, monensin could affect handlers of highly concentrated products by causing irritation of the skin, eyes, and respiratory tract through direct exposure.

People or animals who consume meat or milk from animals exposed to very high levels of monensin are at risk of indirect exposure, which could potentially lead to ingestion toxicity.   Champion Meat Goat Pellets R20, Medicated Feed, was distributed to three consignees in Oregon and Washington between April 20, 2020, and April 29, 2020. NW Farm Supply in Hermiston, Oregon and in Prosser, Washington, further sold the recalled product to downstream customers.

The recalled product is pelleted dry feed and bagged in poly bags with the words Payback Champion Feeds printed on the bag. Each bag weighs 50 lbs. The affected lot number 6705 HM928510 04/17/20 and the UPC code 48252 48640 are printed on the tag of each bag. Customers reported that three goats have died, and three additional goats were ill but have recovered to date. The recalled product was found to contain elevated levels of monensin due to a mixing error during manufacturing. The recalled product was put on hold pending testing after a customer complaint. Test results confirmed a higher than expected level and this recall was initiated. CHS Nutrition cannot account for up to 15 bags out of 510 bags distributed to date.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

June 5, 2020 9:34 AM

“They ignoring customers and giving us raw chicken. See Less
Reported By SafelyHQ.com User

Chicken from Costco is almost raw, Costco Wholesale, 16580 NW 59th Ave, Hialeah, FL 33014, United States

Costco Wholesale, 16580 NW 59th Ave, Hialeah, FL 33014, United States

May 6, 2020 9:35 PM

“Translation:
Honestly, I love Costco, and I'm not trying to put any employee in a bad light, especially in the chicken-rotisserie area. I have a picture of how red hot it is on a piece of ... See Morebtn-link" href="https://safelyhq.com/product/meat#scroll" title="Product: Meat">meat and blood on the bones. Chickens need more fire and cooking.

Original:
Con sinceridad, amo Costco, y no trato de poner en mal a ningun empleado en especial la zona de los asadores de pollo. Tengo la foto lo rojo vivo que esta en una parte de la carne y sangre en los huesos. Los pollos necesitan mas fuego y cocimiento. See Less
Reported By SafelyHQ.com User

June 5, 2020 4:00 PM

“Company name: Teva Pharmaceuticals USA Inc.
Brand name: Actavis
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 05, 2020
Recall details: Teva Pharmaceuticals U ... See MoreSA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.

- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

- NDC: 62037-571-01/ Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1329548A/ Expiration: 06/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1338302M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348968M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348969M/ Expiration: 11/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348970M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1376339M/ Expiration: 09/2021

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1323460M/ Expiration: 06/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1330919M/ Expiration: 06/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1338300A/ Expiration: 10/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1341135M/ Expiration: 12/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1391828M/ Expiration: 11/2021

- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333338M/ Expiration: 08/2020

- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333339A/ Expiration: 08/2020

- NDC: 62037-577-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count/ Lot Number: 1354471A/ Expiration: 02/2021

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

March 15, 2020 4:11 PM

“I walked by Bar PIsellino at 5:21 PM on Sat, March 14 and it was packed inside the restaurant and also in the outdoor seating area. I have a picture. They are clearly not following the requirement to reduce capacity by 50% to help reduce the spread of coronavirus. This is extremely socially irrespo ... See Morensible! See Less
Reported By SafelyHQ.com User