Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Dete…

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Dete…

July 8, 2020 Off By administrator

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

N-Nitrosodimethylamine (NDMA) Impurity

Company Name:
Lupin Pharmaceuticals, Inc.
Brand Name:
Product Description:

Product Description

Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg


Company Announcement

Lupin Pharmaceuticals Inc. is voluntarily recalling 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

Strengths

NDC

Distribution Dates

Metformin Hydrochloride Extended-Release Tablets USP

 

500mg

 

68180-338-01

 

11/21/2018 – 05/27/2020

 

1000mg

 

68180-339-09
500mg 68180-336-07 11/05/2018 – 05/22/2020
1000mg 68180-337-07

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chain,…

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