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Acella Pharmaceuticals, LLC 30-mg, 60-mg and 90-mg NP Thyroid® - recalled due to Super potency, United States

May 22, 2020 4:00 PM

United States

Acella Pharmaceuticals, LLC 30-mg, 60-mg and 90-mg NP Thyroid®  - recalled due to Super potency, United States

Company name: Acella Pharmaceuticals, LLC
Brand name: Acella
Product recalled: 30-mg, 60-mg and 90-mg NP Thyroid®
Reason of the recall: Super potency
FDA Recall date: May 22, 2020
Recall details: Company Announcement Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3). Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received two reports of adverse events known to be related to this recall. NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images. To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts.
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

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Reported By SafelyHQ.com User

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
See Less
Reported By SafelyHQ.com User

March 26, 2020 6:50 PM

“Interview - Mai, Taipei Taiwan:
This is a first-hand account from a restaurant owner in Taipei Taiwan of the coronavirus situation including: how the testing process works in Taiwan, how the country dealt with the initial outbreak, and the effect it has had on the people and businesses.

Mai:
Hi ... See More, I'm Mai. I'm currently based in Taipei, Taiwan and I am a restaurant owner here. I own two vegan cafes here in Taipei. And it's been an interesting time with the virus coming around.

SafelyHQ:
What's the current situation in Taiwan?

Mai:
Actually, I'm sure, I mean it's been getting around on the news pretty steadily in the last week about Taiwan's containment and their efforts to kind of help the spread of the virus and they been doing an amazing job. For us, we've been dealing with it since January, so right when the Chinese government kind of started allowing information to get out, Taiwan was bracing from January. And they were getting ready for the lunar new year, which is a huge travel time for almost every country in Asia. They knew that it was going to be a huge potential risk with everyone traveling around, not just within Taiwan, but internationally. A lot of Taiwanese nationals work in China, so they were planning to fly back to Taiwan. We knew that there was going to be this really big first wave. And Taiwan was really ready for it and a lot of the Asian countries were really ready for it because of the SARS epidemic. They learned a lot from that previous experience and were able to leverage that for this epidemic.

SafelyHQ:
Has testing been easy for people or has that been a problem for some people getting testing?

Mai:
No, testing has been really great here. I think within about a month, one of the universities got the testing time down to about 15 minutes. And all the hospitals, we already have a national healthcare system. Everyone has a national health insurance card if you're working and if you pay taxes and you're registered into the system and all the hospitals are usually prepped and ready to handle a pretty large number of people. Testing was pretty swift here.

SafelyHQ:
There was a second wave that happened after Taiwan initially had slowed up. How did that look and how did that impact everyone?

Mai:
For the first wave coming back, they knew they kind of had to stop and contain the first wave. What they did was they stalled school, they pushed school back about three weeks college and K through 12. Everyone was kind of on an extended holiday from coming back from the Chinese new year. And then for the second wave, once it started exploding in Italy and moving over to the U S they quickly realized that international travel is going to be a huge problem. And another huge problem was because Taiwan did such a good job containing that first wave, there were still some tour groups that were still going abroad because it hadn't spread that far yet. We had some tour groups from Taiwan that went to Egypt and Greece. And so by the time they came back, they were actually carriers. And so that coupled with international travel kind of started the second wave. And that was I think about late February, early March. And so they basically put the airport on lockdown because Taipei is a huge hub. It's a huge international hub. To get into Asia, usually you come through either Japan or Taipei. And so they knew that that airport was a huge risk. But being an Island, a small Island nation, we only have two big airports and the biggest international hub is Taoyuan airport, the Taipei airport. They got a handle on that and we're just screening all the passengers that came in and getting all their information, you're asked to scan a QR code and fill out all your information so that they could track every passenger. At that point you were supposed to be self-monitoring, so no mandatory self-quarantine yet.

SafelyHQ:
What does self-monitoring mean?

Mai:
They have a list of things that you were supposed to be doing. You're supposed to be checking your temperature, being more aware of your respiratory system and basically checking in, that was about it.

SafelyHQ
How has it impacted people's behavior in Taiwan?

Mai:
At first, it was during Chinese New Year. I remember one day I just went out and it was two days into the first reports of the Coronavirus coming into Taiwan. And mask, in Asia mask a normal thing. It's not if you're sick, if you are in a crowded space or you have allergies, it's normal to just wear a mask. No one thinks twice about it. But, I remember as a business owner, I was thinking, I should probably get some mask for my two stores. And I went out and everywhere was completely sold out. And that was when the first information about what kind of masks were needed was coming out cause people were buying all kinds of mask. People were kind of buying the respirators, the PITTA mask. And so that first wave of information was what mask you should be using, what helps, what doesn't help. Taiwan has been really good about trying to fight misinformation, The government constantly, consistently pushes out information to the public. And actually their newest campaign is with this, it's a Shiba. It's a Shiba that's telling you to not cough and wear your mask.

SafelyHQ:
How has this impacted you personally?

New Speaker:
That first few weeks when we're trying to find masks, we realize, this is going to be really serious. But the government seemed to have a handle on it because when that first mask panic buying happened, the government quickly stepped in and took mask off out of the private sector and they started rationing and only giving it to pharmacies which were covered by national health insurance. Then if you had a national health insurance card, you would go and they would scan you and then you would get a certain ration mask and then they increase production greatly. We realized that the government was going to handle this pretty well. But we started seeing the real effects of it, maybe for the second wave, the first wave we were okay. There was no social distancing or anything like that. But the second wave is when the government started pushing out no large gatherings, everyone needs to be taking their temperature. We've had to kind of put in new protocols at the restaurant. We currently hand sanitize everyone that comes in. Temperature checks are almost done at every place now. All the staff needs to be wearing masks at all times. And we've asked that anyone that's traveled internationally in the last 14 days to either stay at home or we don't allow them entry into the location. We've had to think really hard about how to make customers feel safe and guarantee my staff safety. That's been a huge, every day struggle to make sure that the staff really understands the seriousness and severity of this. And when offices went remote, that actually when it hit us the most, cause in one of our areas we have a lot of technology companies. And when they went remote we saw a huge decline in our daytime lunch customers. That was, that was a scary week. That was a really scary week.

SafelyHQ:
Do you expect that restaurants and other businesses will be able to remain open for the near term?

Mai:
So far there's hasn't been any talk of shutting down restaurants. Clubs have been voluntarily closing and some of the city governments have closed down and movie theaters and gyms, kind of large gathering places and the government has asked for gatherings, no larger than a hundred people. Anything above a hundred people has to be canceled. But Taiwanese people are really a little bit conservative so they are already pretty risk-averse. They are just kind of doing these social distancing, self-isolation things by themselves. A lot of communities have just decided to cancel their events, go online, make them all available online. The government hasn't had to mandate, closures. Some restaurants that are really popular have decided to do delivery only just to be on the safe side. They've taken these voluntary measures actually.
SafelyHQ:
Now that you've been impacted by Coronavirus, do you have any message to people or any recommendations to people based on your experience?
Mai:
I'm kind of seeing what's happening in other countries through news and my family, and hearing it from them. I think the biggest thing is the social responsibility that everyone should feel towards the greater community. Part of why Taiwan has been so successful is there is a very clear understanding that all the policies are for the greater community. You as an individual might not be necessarily affected or be in grave danger if you get the virus, but kind of there's this understanding that there are a lot of people at risk and so what you do is to keep those people protected. That's been really amazing to see. I would say the advice is to just try to think about the greater community and that your actions kind of ripple out and take care of each other.
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Reported By SafelyHQ.com User

March 25, 2020 12:41 PM

“The company’s Soho location closed earlier this week. The employee who tested positive for COVID-19 was last in the Soho store on Tuesday, March 17, according to a company spokesperson. It’s still up-in-the-air when the Soho Trader Joe’s will reopen, but standard protocol is to close at least three ... See Moredays for cleaning.

“Out of an abundance of caution, we have temporarily closed the store for thorough cleaning and sanitization. As soon as the store has been fully cleaned and restocked, we plan to reopen,” Trader Joe’s said in an announcement on their website.
Source: ny.eater.com
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Reported By SafelyHQ.com User

May 15, 2020 11:00 AM

“Company name: Summitt Labs
Brand name: KORE ORGANIC
Product recalled: Watermelon CBD oil tincture
Reason of the recall: Contains lead
FDA Recall date: May 15, 2020
Recall details: Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle ... See More, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. As part of this investigation Summitt Labs had a sample from Batch #730 Lot #K018 tested at an ISO/IEC accredited lab. Lead results were 500 ppb (.5ppm), which is within the legal limits as defined by the State of Florida. However, based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services.

Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Consumer Services to produce products containing CBD but the Federal Food and Drug Administration does not consider CBD to be a legal drug or dietary supplement. Ingestion of KORE ORGANIC Watermelon CBD Oil Batch #730 Lot #K018 containing lead could result in high lead exposure. According to the Florida Department of Health, acute lead poisoning could have signs and symptoms including but not limited to; Pain, Muscle Weakness, Paresthesia, Abdominal Pain, Nausea, Vomiting, Diarrhea, Constipation, Poor appetite, Weight Loss, Symptoms associated with encephalitis, Metallic taste in the mouth, Shock, Hemolysis, and Kidney Damage. To this date, Summitt Labs has not had a call, complaint or report of any adverse effect from the use of this product.

The product labels states that benefits may include, Anxiety Relief, Pain Reduction, Mood Enhancer, Restful Sleep and may Alleviate Stress. The product is packaged in 30 milliliter bottles; which could come in 9 count displays in Kraft paper packaging. The affected Kore Organic Watermelon CBD Oil lots include Batch#730 Lot#K018. The Product can be identified by the Kore Organic Logo and Kraft Paper Packaging on the 30 milliliter bottle. The product was distributed nationwide by Wholesalers (I.E. Nirvana Kulture and North East Rally), Samples by Sales Personnel, Tradeshow Samples, and by Summitt Labs. Summitt Labs is notifying its distributors and customers by email, phone, and personal visits to ensure the return of all recalled product.

Consumers, distributors and retailers that have Kore Organic Watermelon CBD Oil Batch #730 Batch #K018, which is being recalled, should stop using the product. Any consumer with Lot #K018 Batch #730 should return this product to the place of purchase for a full monetary refund. If that is denied, please contact Summitt Labs at the above number for refund information and any other information regarding this recall.

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.

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

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

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

Symptoms, Cranston, RI, USA

Cranston, RI, USA

April 8, 2020 4:39 PM

“Headache, nasal congestion. Have not been around anyone in 3 weeks.....did not leave the house often at all expect the drive thru at Target and Gas. See Less
Reported By SafelyHQ.com User