Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case! Your contact information is not shown on the website.
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Use camera
Select from library
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!
IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)
Visit our learn pages for more helpful information or, email us: support@safelyhq.com
Goodbye! and best wishes in your recovery
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

If your report is poison related call 1-800-222-1222 for a free consultation with a live medical poisoning expert

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Metformin Hydrochloride Extended-Release Tablets, USP 500mg - recalled due to Due to detection of N-Nitrosodimethylamine (NDMA), USA

June 5, 2020 5:00 PM

United States

Metformin Hydrochloride Extended-Release Tablets, USP 500mg - recalled due to Due to detection of N-Nitrosodimethylamine (NDMA), USA

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 Limited, 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

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

Related Reports

August 1, 2020 5:01 PM

“Company name: Laboratorios Jaloma S.A. de C.V.
Brand name: Jaloma
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: August 01, 2020
Recall details: Company Announcement LABORATORIOS JALOMA S.A. de C.V. is voluntarily recalling all lots and all bottle s ... See Moreizes of the Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E to the consumer level. This recall has been initiated because FDA sampled the 500 mL product and found it to be contaminated with undeclared methanol (wood alcohol). Although the contamination was linked to the 500 mL product, due to the abundance of caution, Jaloma is recalling all lots of all sizes within expiry. The NDCs, lot #s, and expiration dates are listed in the table below. Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and 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. To date, LABORATORIOS JALOMA S.A. de C.V. has not received any reports of adverse events related to this recall. Recalled Products
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

July 31, 2020 10:01 PM

“Company name: Albek de Mexico S.A. de C.V
Brand name: Nuuxsan, Modesa, Assured, more
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 31, 2020
Recall details: Company Announcement Albek de Mexico S.A. de C.V is voluntarily recalling all lots and ... See Moreall brands of hand sanitizer currently in US distribution to the consumer level. This recall is being initiated out of an abundance of caution due to detection of methanol in hand sanitizer samples manufactured by Albek when product was presented for import into the United States. Risk Statement: Substantial methanol exposure could result in serious health effects (including nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, nervous system damage) or death. Persons using methanol-based products on their hands may be at risk. Young children who accidently ingest them and adolescents and adults who drink such products are most at risk for methanol poisoning. To date, there have been no reports of serious adverse events related to the products in the scope of this recall. The products are labeled for use as a hand sanitizer (or “antiseptic”) and are packaged for several nationwide distributors in a variety of formats as indicated in the table as follows:
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

July 28, 2020 9:00 PM

“Company name: Broncolin S.A. de C.V
Brand name: Herbacil
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 28, 2020
Recall details: Broncolin S.A. de C.V is voluntarily recalling all lots of Herbacil Antiseptic Hand Sanitizer 70% Alcohol to the co ... See Morensumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

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." To date, Broncolin S.A. de C.V. has not received any reports of adverse events related to the product in question.

The product is an alcohol-based hand sanitizer used to reduce bacteria that potentially cause disease when soap and water are not available and is packaged in 4 bottle sizes; 4.22 fl. oz. (125ml), 8.4 fl. oz. (250 ml), 16.9 fl. oz. (500 ml) and 33.8 fl. oz. (1 Liter). It is a clear plastic bottle with a pump or squeeze cap. All package sizes are labeled with a blue label identifying INBC Trading LLC 4404 Merle Drive, Austin, TX 78745 as the Importer/Distributor (see attachments). Herbacil Antiseptic Hand Sanitizer 70% Alcohol was distributed by the importer/distributor between April 26, 2020 to May 18, 2020 , to wholesalers in Arizona, California, Florida, Georgia, Illinois, Maryland, New Jersey, New York, North Carolina, South Carolina, and Texas and further distributed Nationwide in the USA.

Broncolin S.A. de C.V via INBC Trading LLC is notifying all US customers by email and is arranging for the return of all recalled products. Consumers, distributors, and retailers that have recalled Herbacil hand sanitizer, should stop using and return to the 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.

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

July 28, 2020 2:00 AM

“Company name: Resource Recovery & Trading, LLC
Brand name: Resource Recover & Trading, LLC
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol subpotency ethyl alcohol
FDA Recall date: July 27, 2020
Recall details: RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling ... See Moreall the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) liter plastic containers, UPC 37710600013 to the consumer level. The products are being recalled due to the potential presence of undeclared methanol (wood alcohol) and subpotency ethyl alcohol.

Risk Statement: The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreased bactericidal and virucidal activity. Adverse health consequences can be related to increased infections. In addition substantial, undeclared methanol exposure, which has inferior antiseptic properties compared to ethanol, 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, RESOURCE RECOVERY & TRADING LLC has not received any reports of adverse events related to this recall. The product is used as a hand sanitizer to decrease germs when soap and water is not available and is packaged in 200 ml plastic bottles and 20 liter plastic containers. The product can be identified by the label attached. The product was distribution between June 10, 2020 and June 20, 2020 in the states of Alabama and Georgia.

RESOURCE RECOVERY & TRADING LLC is notifying its distributors and customers by phone calls and emails and is arranging for return 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 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.

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

July 27, 2020 6:00 PM

“Company name: 4e Brands North America
Brand name: Assured, Blumen, Modesa
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: July 27, 2020
Recall details: San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer bra ... See Morends to the consumer level. These products are being recalled due to the potential presence of methanol (wood alcohol).

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.

RECALLED PRODUCTS These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. This recall now includes all product manufactured by 4e within expiration, regardless of the size, UPC, or lot number. For full details and products click the link below.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

July 24, 2020 8:01 PM

“Company name: Maquiladora Miniara, S.A. de C.V.
Brand name: Shine & Clean
Product recalled: Hand Sanitizer Gel
Reason of the recall: Potential presence of methanol (wood alcohol)
FDA Recall date: July 24, 2020
Recall details: Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shi ... See Morene and Clean Hand Sanitizer gel 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 accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning Maquiladora Miniara S.A. de C.V. has not received any reports of adverse events related to this recall.

These products are used as topical hand sanitizers. The affected Shine and Clean Hand Sanitizer Gel is packaged in 1000 ml bottles and 1-gallon containers. Shine and Clean Hand Sanitizer gel were distributed Nationwide to retail stores via distributors. Lot numbers:

F200829088/F200829095/F200829107/D202728743/D202528742/D202428733/D202728743/
D2028753/D202528742/D202428733/ D202028689/ D201828660/D202428734/
E200128784/E200418795/D202428734/D202828689/D201828660/E201628912/E201628913/
E201628911/E201528902/E201528903/E201628910/E201628918/E201628914/E201628915/
E201628916/E201628917/ E202328969/E202428975/ E202528981 /E202128947/E201728918/
E201728919/E201428876/ E201828894/E201828920/E201428876/E201128850/E201328859/
E200628817/E200828826/E200928840/D202128699/D202428700.

Maquiladora Miniara S.A. de C.V. is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Distributors that have Shine and Clean Hand Sanitizer which is being recalled, should stop using and distributing product and contact their clients.

Consumers who have questions about this recall can contact Maquiladora Miniara S.A. de C.V. By +52 55 33871987 + 52 55 8394 5857 the hours are available from 10:00 a.m. to 1:00 p.m. and from 2:00 p.m. to 4:00 p.m. Consumers should contact their doctor or healthcare provider if they have experienced any problems related to taking or using this medicine.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

July 24, 2020 12:00 PM

“Company name: Real Clean Distribuciones SA de CV
Brand name: Born Basic, Scent Theory and more
Product recalled: Hand Sanitizer
Reason of the recall: Undeclared methanol
FDA Recall date: July 24, 2020
Recall details: La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntari ... See Morely recalling all lots it manufactured within expiry of the following brand names of hand sanitizers:
- Born Basic ANTI-BAC HAND SANITIZER
- Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer
- Scent Theory KEEP IT CLEAN Moisturizing Hand Sanitizer
- Lux Eoi Hand Sanitizing Gel to the consumer level.

The products are being recalled due to the potential presence of methanol (wood alcohol).

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. To date, Real Clean Distribuciones SA de CV has not received reports of adverse events related to this recall.

RECALLED PRODUCTS These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. Real Clean Distribuciones SA de CV manufacturers product for four brands included in this recall. Scent Theory and Born Basic hand sanitizer products are produced by several different manufacturers, in several different countries, and only those lots manufactured by Real Clean in Mexico are subject to the recall. The recalled products include the following lots:

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Scent Theory Keep Clean Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 1633220, 1733220, 1833220, 1933220, 2033220, 2133220, 2233220, 2333220, 2433220, 2533220, 2633220, 2733220, 2833220, 2933220, 3033220, 3133220, 3233220, 3333220, 3433220, 3533220, 3633220, 3733220, 3833220, 3933220, 4033220, 4133220

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Keep it Clean Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0833420, 0933420, 1033420, 1133420, 1233420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2233420, 2333420, 2433420, 2533420, 2633420, 2733420, 2833420, 2933420

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 34oz
Lot Numbers: 0133420, 0233420, 0333420, 0433420, 0533420, 0633420

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Born Basic Anti-Bac Hand Sanitizer 70% Alcohol
Country of Origin: Mexico
Size: 9.5oz
Lot Numbers: 0133720, 0233720

Manufacturer: Real Clean Distribuciones S.A. De C.V
Product: Lux Eoi Hand Sanitizing Gel
Country of Origin: Mexico
Size: 16.9oz
Lot Numbers: 0133920, 0233920, 0333920

Real Clean Distribuciones SA de CV is notifying its distributors by recall letter and consumers via this press release. Real Clean Distribuciones SA de CV is arranging for the return and refund of all recalled products.

Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/selling Hand Sanitizer and return it to the place of purchase; because the affected products are considered hazardous materials, do not destroy the affected products.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

July 22, 2020 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Dexmedetomidine Hydrochloride Injection, 200 mcg/50 mL
Reason of the recall: Cross contamination with lidocaine
FDA Recall date: July 22, 2020
Recall details: Fresenius Kabi USA is voluntarily recalling two lots of De ... See Morexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Below there is a list of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between June 3, 2019 and April 8, 2020, as well as a copy of the label:

Product Name/Product size: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial
NDC Number: 63323-671-50
Product Code: 671050
Batch Number: 6121853 - 6122207
Expiration Date: 05/2021 - 06/2021
First Ship Date 06/03/2019 - 12/04/2019
Last Ship Date: 03/12/2020 - 04/08/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.

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

July 20, 2020 6:01 PM

“Company name: LIQ-E S.A. de C.V.
Brand name: Optimus
Product recalled: Hand Sanitizer
Reason of the recall: Potential Methanol Contamination
FDA Recall date: July 20, 2020
Recall details: SAN NICOLAS DE LOS GARZA, Mexico -- LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle s ... See Moreizes of The OPTIMUS Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol) that were shipped into the United States. The products were manufactured between April 27, 2020 and May 08, 2020. Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and 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. To date, LIQ-E S.A. de C.V. has not received any reports of adverse events related to this recall.

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-002-01
Sizes: 8.5Fl Oz.(250 mL)
UPC: 7501799115621
Lot #s & Expiration Dates: (L) 20-02 EXP 05/2022

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-001-04
Sizes: 55 Gal (208 L)
UPC: 7501799118998
Lot #s & Expiration Dates: See List

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-378-04
Sizes: 1 GAL (3.78L)
UPC: 7501799118837
Lot #s & Expiration Dates: (L) 20-03 EXP 05/22

Recalled Products: Optimus Instant Hand Sanitizer
Product(s) NDCs: 75416-004-01
Sizes: 275 Gal (1,040 L)
UPC: 7501799118981
Lot #s & Expiration Dates: (L) 5200 EXP 05/2022

55 Gal Blue Drum Lot Numbers: L-1160 EXP 05/2022 ; L-2160 EXP 05/2022 ; L-3160 EXP 05/2022 ; L-1180 EXP 05/2022 ; L-2180 EXP 05/2022 ; L-2190 EXP 05/2022 ; L-1200 EXP 06/2022 ; L-2200 EXP 06/2022 ; L-3200 EXP 06/2022 ; L-4200 EXP 06/2022 ; L-5200 EXP 06/2022 ; L-1210 EXP 06/2022 L-2210 EXP 06/2022

Master Cartons Lot Numbers:
L-1150 L-2150 L-3150 L-4150 L-5150 L-6150
L-1160 L-2160 L-3160 L-4160 L-5160 L-6160
L-1170 L-2170 L-3170 L-4170 L-5170 L-1180
L-3180 L-4180 L-6180 L-1190 L-2190 L-3190
L-4190 L-5190 L-6190 L-1200 L-2200 L-3200
L-4200 L-5200 L-6200 L-2180

The Hand Sanitizer is distributed in a 55 Gal (208 L) plastic blue drum and in 8.5Fl Oz. (250 mL), 1Gal (3.78 L), and 275 Gal (1,040L) clear plastic HDPE bottles or tank. All are labeled with a green and white label. The product was distributed throughout the United States.

Each product contains a lot number consisting of a letter followed by a dash four digits (example L-1180). This number can be found on the master cartons and written in black pen on the 55 Gal blue drum and the 275 Gal plastic tank.

The individual bottles are labeled with a lot number and expiration date in the format below. See table for lot numbers of each individual bottle.

(L) 20-02 EXP 05/2022

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

July 18, 2020 12:37 AM

“Company name: InHE Manufacturing, LLC
Brand name: Multiple brand names
Product recalled: Hemp Oil Tinctures
Reason of the recall: Excess lead in product
FDA Recall date: July 17, 2020
Recall details: Company Announcement This recall press release was issued by the firm on 06-23-2020 and is subs ... See Moreequently being posted by FDA at this time only to benefit the public for informational purposes.

Human Consumption (MHR Brands):

- Tasty Drops – Berry Tincture, 1oz/300mg FG003175

- Tasty Drops – Berry Tincture, 1oz/500mg FG003137 FG003174, FG003197, FG0057

- Tasty Drops – Berry Tincture, 1oz/1500mg FG003141, FG003202, FG003296

- Tasty Drops – Natural Tincture, 1oz/500mg FG003138, FG003248

- Tasty Drops – Natural Tincture, 1oz/1500mg FG003142, FG003247

- Tasty Drops – Spearmint Tincture, 1oz/300mg FG003167

- Tasty Drops – Spearmint Tincture, 1oz/500mg FG003139, FG003166, FG003191, FG003225, FG003253, FG003263

- Tasty Drops – Spearmint Tincture, 1oz/1000mg FG003095

- Tasty Drops – Spearmint Tincture, 1oz/1500mg FG003143, FG003180, FG003201, FG003224, FG003262

- Tasty Drops – Vanilla Tincture, 1oz/300mg FG003126

- Tasty Drops – Vanilla Tincture, 1oz/500mg FG003140, FG003182, FG003246

- Tasty Drops – Vanilla Tincture, 1oz/1500mg FG003144, FG003249

- Made by Hemp – French Vanilla Tincture, 1oz/1000mg FG003107

- Made by Hemp – Mojito Lime Tincture, 1oz/1000mg FG003110

- Made by Hemp – Strawberry Crème Tincture, 1oz/1000mg FG003109

Pet Consumption (White Label)

- Herbal Renewals – Cat Tincture, 1oz/200mg FG003213

- Herbal Renewals – Pet Blend, 1oz/200mg FG003223, FG003310

- Barkley Bistro – Dog Tincture, 1oz/200mg FG003145

- A Clean Choice – Cat Tincture, 1oz/200mg FG003117

- A Clean Choice – Cat Tincture, 500mg/1oz FG003118

- A Clean Choice – Dog Tincture, 1oz/200mg FG003116

- A Clean Choice – Dog Tincture, 500mg/1oz FG003115

- BC Hemp Co LLC – Pet Tincture, 1oz/200mg FG003165

- Boost IV Hydration, LLC – Dog Tincture, 1oz/200mg FG003270

- Acadia Farms – Pet Blend, 1oz/200mg FG003176

How the company learned of this situation: The Company was recently advised by the Florida Department of Health of the presence of elevated heavy metals (lead) in some of its products.

Exposure to lead could present physical signs and symptoms including, pain, paresthesia/muscle weakness, abdominal pain, nausea, vomiting, diarrhea, constipation, poor appetite, weight loss, symptoms associated with encephalitis, metallic taste in the mouth, shock, hemolysis or kidney damage.

Consumers should contact their physician or healthcare provider if they experience any symptoms that may be related to using the products being recalled. Consumers should observe pets and contact their veterinarian as signs and symptoms of lead exposure in pets may be similar to those in humans.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Recent Interesting Reports

Raw Salmon, Applebee's, Rainbow Boulevard, Kansas City, Kansas, USA

Symptoms: Other
Applebee's, Rainbow Boulevard, Kansas City, Kansas, USA

December 21, 2019 1:38 PM

“Me and my boyfriend went to there and ordered salmon off the 2 for 30 offer the salmon was cooked on the ... See Moreoutside but raw on inside the waiter immediately came and took the plate and gave us their mangers card in case we ended up at the hospital. This happened Dec 20 2019 See Less
Reported By SafelyHQ.com User

April 12, 2020 12:00 PM

“Details: Shearer's Foods confirmed Thursday that an employee in its Perham manufacturing location has tested positive for COVID-19.
The employee has been asked to self-quarantine at home for 14 days and has not come in contact with the product so there is no food safety risk.

Report: 4/10/2020 ... See MoreSource: perhamfocus.com See Less
Reported By SafelyHQ.com User

July 13, 2020 1:00 PM

“Company name: Ridley Block Operations
Brand name: Ultralyx
Product recalled: 12% Protein Sheep feed
Reason of the recall: Elevated levels of copper
FDA Recall date: July 13, 2020
Recall details: No other products are affected Ridley Block Operations is voluntarily recalling Ultralyx® 12% Protei ... See Moren Sheep with batch number HB01679401. The product has been found to contain elevated levels of copper. With prolonged consumption, the affected product could potentially have adverse health effects on sheep, including reductions in daily gains, icterus, partially cirrhotic livers and hemoglobin-stained kidneys. Occasionally, death occurs in copper-toxic sheep.

This recall relates only to Ultralyx 12% Protein Sheep with the following batch numbers printed on the package:

- Product Name: Ultralyx 12% Protein Sheep
- Batch/Lot# : HB01679401
- Item No./Product No.: 24419
- Package Info.: 50# Block

Customers are asked to remove all product matching this batch number from distribution and inventory and discontinue feeding it immediately.

No other batch number or other Ridley Block Operations products are involved in this voluntary recall. Of the batch of twenty blocks included in the recall, two blocks remain in the marketplace.

Ridley Block Operations will continue to work closely with the Food and Drug Administration throughout the recall process. Our representatives are in direct communication with our customers to ensure the proper identification and removal of the impacted products.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

April 20, 2020 6:00 PM

“Company name: Braun Medical Inc
Brand name: B. Braun
Product recalled: Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container
Reason of the recall: Out-of-Specification Results for High Molecular Weight Polymers
FDA Recall date: April 20, 2020
Recall de ... See Moretails: Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the nineteen (19) month [82 week] stability interval. Elevated levels of High Molecular Weight Polymers have been shown to cause kidney damage and liver issues in animal studies. While the impact of HMWP in humans is unknown, B. Braun is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels.

To date there have been no complaints or reports of adverse reactions associated with this product lot. Ceftazidime for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Lower respiratory tract infections; skin and skin-structure infections; bacterial septicemia; bone and joint infections; gynecologic infections; intra-abdominal infections; and central nervous system infections.

Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container containing approximately 50 mL of 5% Dextrose Injection in the diluent chamber and ceftazidime in the drug powder chamber. After reconstitution, the concentration is equivalent to 2 g ceftazidime. Ceftazidime for Injection USP and Dextrose Injection USP is packaged in 24 DUPLEX® Containers per case. The affected recalled product includes the following lot number and expiration date:

- NDC: 0264-3145-11. Ref: 3145-11. Dose/Volume: 2 g per 50 mL. Impacted batch: H8J812. Exp. Date: 31 Jul 2020.

Product was distributed Nationwide within the United States to domestic distributors. Pictures of the product and product labeling follow this press release.

B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Glass in food, Serial Grillers (Speedway Blvd.), East Speedway Boulevard, Tucson, AZ, USA

Serial Grillers (Speedway Blvd.), East Speedway Boulevard, Tucson, AZ, USA

March 6, 2020 11:19 PM

“There was glass in my husband's food. Called and reported it and the manager didn't care but acted as if we made it up. See Less
Reported By SafelyHQ.com User

July 6, 2020 12:53 PM

“Order from Walmart delivers. SOUTHERN HENS (frozen chicken.)
When thawed and removing giblets, to my horror, there was a brow ... See Morele="Product: Egg">egg inside the hen!!!! The inside of the egg had dispersed but the shell was partly attached to itself. Contacted company and they told me that they had never heard of anything like this before... I have pics!!!!! Reported to Walmart and they are STILL SELLING THEM!!!!!
I would also like to name all the agencies in MS That I contacted and they kept telling me they were not responsible?!? Six Mississippi agencies where this plant is located...Yet Walmart keeps selling them!!
I called the Board of Health in Mississippi, I called the FDA, the USDA, I called Southern Hen and spoke to a person. There was no action taken, none! nobody cares that there was a frickin egg inside of a frozen hen See Less
Reported By SafelyHQ.com User

May 7, 2020 1:00 PM

“Company name: Becca Cosmetics
Brand name: Becca Cosmetics
Product recalled: Light Shifter Brightening Concealer
Reason of the recall: Potential Mold
FDA Recall date: May 07, 2020
Recall details: Company Announcement Out of abundance of caution, and in line with its commitment to consumer sat ... See Moreisfaction and safety, Becca Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common household mold was found on the sponge-tip applicator of some units. While this is unlikely to cause serious injury there is a potential risk of temporary skin and/or eye allergy and irritation.

To date, no adverse reactions or injuries have been reported. This product was manufactured in the United States and distributed nationwide. The below are the details of the product affected by this recall. No other Becca Cosmetics products are affected by this issue.

- Product Name: Becca Cosmetics Light Shifter Brightening Concealer
- Batch: 0030A, 9308A, 0052A, 0052C, 9291A, 9309A, 0036A, 0037A, 0038A, 0038B, 0041A, 9289A, 0062A, 0062B, 0062C, 9283A, 9284A, 9287A, 9288A
- Size: 3.2 mL (only size available)
- Product Description: Concealer wand with silver overlay, and a white secondary carton
- UPC: 9331137030037, 9331137030044, 9331137030051, 9331137030068, 9331137030075, 9331137030099, 9331137030082, 9331137030105

If you have this product, please stop using it and contact the place of purchase regarding a refund. 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

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
See Less
Reported By SafelyHQ.com User

June 12, 2020 1:54 PM

“Had a glorious experience of eating raw chicken thanks to my lunch order from your location. I called your customer service was told the issue would be escalated to a regional manager. Emailed the s ... See Moretore as well. 5 hours later still no response See Less
Reported By SafelyHQ.com User

June 15, 2020 2:43 PM

“Bone fragment in Carl Budding meat packets. Mixed chicken and ... See Moreom/product/honey#scroll" title="Product: Honey">honey ham so not sure which one. See Less
Reported By SafelyHQ.com User