Glenmark, Granules, and Zydus have recalled their medicines from the US. Find out why.
Indian pharmaceutical companies Glenmark, Granules India, Sun Pharma, Zydus, and Unichem are recalling their medicines from the US market due to various manufacturing defects. The US Food and Drug Administration (USSDA) has issued this information. In its latest enforcement report, the USSDA stated that these pharmaceutical companies are voluntarily recalling the affected lots from the US market. The US Food and Drug Administration stated that a US subsidiary of Mumbai-based Glenmark Pharmaceuticals has recalled 13,824 azelaic acid gel tubes manufactured at its Goa plant due to complaints of roughness in the texture.
Why is Glenmark Pharmaceuticals recalling medicines?
New Jersey-based Glenmark Pharmaceuticals Inc., USA, initiated the Class II nationwide recall on September 17. According to the USSDA, a Class II recall is initiated when use or exposure to the violative product may result in temporary or medically reversible health consequences, or when the likelihood of serious adverse health consequences is minimal.
Granules India also recalled several drugs from the US
The USSDA said Hyderabad-based Granules India has recalled more than 49,000 bottles of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules due to impurities/failing decay specifications. The US Food and Drug Administration said a US subsidiary of pharmaceutical company Sun Pharma is recalling 1,870 kits of the renal imaging agent.
Zydus and Unichem Pharma have also recalled their drugs from the US. Similarly, Ahmedabad-based pharmaceutical company Zydus Pharmaceuticals (USA) Inc. is recalling 8,784 bottles of the antiviral drug entecavir tablets. Another Indian pharmaceutical company, Unichem Pharmaceuticals USA Inc., is recalling the bottles due to a label defect, the USSDA said.
