Teva recall heart drug after carcinogen found in API

pharmafile | June 14, 2019 | News story | Medical Communications API, Contamination, NMDA, Teva, carcinogen, pharma, recall 

Teva Pharmaceuticals has expanded its recall of losartan potassium tablets after detecting a possible carcinogen in an active pharmaceutical ingredient (API).

The Israeli drugmaker has expanded the recall to include six more batches of the drug after finding the possible carcinogen N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in an API.

The NMBA in the drugs was detected in an API manufactured by Indian firm Hetero Labs Limited. The API had been used to manufacture six bulk loads of the drug.

The contaminated drugs were sold exclusively to the US-based distributor Golden State Medical Supply of Camarillo, California.

The recall comes after the FDA recalled tens of products in July 2018 after NMDA was found in an API manufactured by Chinese firm Zhejiang Huahai Pharmaceuticals.

Aurobindo Pharma later initiated a recall in November of last year after discovering the probable carcinogen, N-nitrosodiethylamine (NDEA) in batches of their blood pressure drug Ibesartan.

Louis Goss

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