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Metformin Hydrochloride Extended-Release Tablet Recall

Three Metformin Drug Manufacturers Recall Medication Due to Potential Carcinogen WASHINGTON, D.C. — The U.S. Food and Drug (FDA) administration announced that three drug manufacturers initiated voluntary recalls of its metformin medication due to the presence of a potential human carcinogen. The Miami Herald identified the three drug makers that commenced metformin recall campaigns as […]

Three Metformin Drug Manufacturers Recall Medication Due to Potential Carcinogen

Metformin hydrochloride extended-release tablet recall

Metformin hydrochloride

WASHINGTON, D.C. — The U.S. Food and Drug (FDA) administration announced that three drug manufacturers initiated voluntary recalls of its metformin medication due to the presence of a potential human carcinogen. The Miami Herald identified the three drug makers that commenced metformin recall campaigns as Apotex Corporation, Teva Pharmaceuticals USA, Inc., and Marksans Pharma Limited. The FDA indicated that any patient who has any remaining quantities of metformin recall by any of the three drug manufacturers must return the drug to the pharmacy where the patient made the purchase. The FDA also indicates that any person who returns their prescription to their pharmacy because of the recall should do so only after consulting their physician about substituting an appropriate medication. The FDA expressed concern about the amount of NDMA, a possible human carcinogen, found in the recalled medication.

Apotex Corporation recalled is Metformin Hydrochloride Extended-Release Tablets in the United States as a precautionary measure. Apotex previously ceased sales of its 500 mg, USP, Metformin Hydrochloride Extended-Release Tablets. However, the company noted that some samples remain on the market. Consequently, the company commenced a voluntary recall campaign.

Teva Pharmaceuticals also recalled fourteen lots of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, as well as 750 mg quantities. Teva Pharmaceuticals distributed the recalled medication in bottles ranging from 100-count to 1,000-count packages in the United States.

Marksans Pharma Limited is a company operating out of India. The international drug maker recalled its Metformin Hydrochloride Extended-Release Tablets, lots number XP9004, USP, in 500 mg doses. The recalled drugs have an expiration date of December of 2020. Time-Cap Labs, operating out of Farmingdale, New York, distributed Marksans Pharma Limited’s metformin in the United States.

Patients taking any of the recalled medicines should contact their physician immediately to obtain a substitute prescription. Additionally, any questions or adverse events should be reported to the FDA as soon as possible.

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