Two more medications containing metformin have been recalled

Two more medications containing metformin have been recalled due to contamination with N-Nitrosodimethylamine (NDMA), a probable carcinogen.

Lupin Pharmaceuticals, Inc. announced on Wednesday that they are voluntarily recalling all batches of their 500mg and 1000mg Metformin Hydrochloride Extended-Release Tablets USP.

…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,” stated a company announcement.

The 500mg and 1000mg medications were packaged in 60, 90 and 100 count bottles and were distributed across the United States. The NDC numbers recalled are 68180-338-01, 68180-339-09, 68180-336-07 and 68180-337-07.

Granules Pharmaceuticals, Inc., announced on Friday that they are voluntarily recalling 12 lots of 750mg Metformin Hydrochloride Extended-Release Tablets USP in 100 and 500 count bottles. This recall was also due to contamination with NDMA.

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,” stated a company announcement.

The company announcement notes that “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.”

Metformin is a diabetes medication. Five other recalls of medications containing metformin have occurred recently, all due to NDMA contamination:

Apotex Corp. voluntarily recalled 500mg Metformin Hydrochloride Extended-Release Tablets, USP on May 27. The NDC number recalled was 60505-0260-1.

Amneal Pharmaceuticals LLC voluntarily recalled all lots of 500mg and 750mg Metformin Hydrochloride Extended Release Tablets, USP on May 29.

Marksans Pharma Limited voluntarily recalled their 500mg Metformin Hydrochloride Extended-Release Tablets, USP with an NDC number of 49483-621-01 on June 2.

Teva Pharmaceuticals USA, Inc. voluntarily recalled 14 lots of 500mg and 750mg Metformin Hydrochloride Extended-Release Tablets on June 2.

Lupin voluntarily recalled a single lot of 500mg Metformin Hydrochloride Extended-Release Tablets USP on June 11. Its NDC number was 68180-336-07.

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Nadrich & Cohen, LLP

Nadrich & Cohen, LLP is a California personal injury law firm with offices in Los Angeles, San Francisco, Modesto, Fresno, Tracy and Palm Desert. The firm has been representing victims of dangerous drugs since 1990 and has recovered over $350,000,000 on behalf of clients in that time.

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