Sun Nov 17 07:31:54 UTC 2024: **US Recalls Generic Drugs from Indian Manufacturers**
**New Delhi, November 17, 2024** – The US Food and Drug Administration (USFDA) announced the recall of several generic medications manufactured by Indian pharmaceutical companies Dr Reddy’s Laboratories and FDC Ltd. due to manufacturing defects.
Dr Reddy’s Laboratories Inc., the US subsidiary of the Mumbai-based company, is recalling over 2,500 bottles of Morphine Sulfate extended-release tablets in various strengths. The recall, classified as Class II, was initiated on October 22nd due to failed impurity and degradation specifications. Morphine Sulfate is used to treat severe pain.
Separately, FDC Ltd. is recalling 155,232 bottles of Timolol Maleate ophthalmic solution, a medication for glaucoma, due to defective containers preventing dispensing of the solution. This Class II recall, initiated on October 29th, poses a risk of temporary or reversible health consequences, according to the USFDA.
The recalls highlight the ongoing scrutiny of generic drug manufacturing, even from India, the world’s largest supplier of generics, accounting for roughly 20% of the global market. While the FDA classifies these recalls as low risk, they underscore the importance of rigorous quality control measures in the pharmaceutical industry.
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