Dr Reddy's and FDC Ltd Recall Medications in US Amid Manufacturing Concerns
Dr Reddy's Laboratories and FDC Ltd are recalling medications in the US due to manufacturing issues, as per the USFDA. Dr Reddy's is recalling Morphine Sulfate due to impurities, while FDC Ltd is recalling Timolol Maleate due to container defects. Both recalls are Class II.
- Country:
- India
In a significant move, Dr Reddy's Laboratories and FDC Ltd have initiated the recall of certain medications in the US, prompted by concerns over manufacturing standards. The recalls have been issued as stipulated by the latest US Food and Drug Administration (USFDA) Enforcement Report.
Dr Reddy's Laboratories, through its US-based subsidiary, is pulling various strengths of Morphine Sulfate extended-release tablets from the market. These tablets, crucial for managing severe and persistent pain, are being withdrawn due to failures in impurity and degradation specifications, affecting nearly 2,572 bottles in total.
Meanwhile, Mumbai-based FDC Ltd is addressing issues with Timolol Maleate ophthalmic solution, used for treating high intraocular pressure from glaucoma. The recall, affecting over 150,000 bottles, was necessitated by a defective container design which prevents proper delivery of the medication. Both recalls are categorized as Class II by USFDA, indicating that usage of these products could lead to temporary or medically reversible health consequences.
(With inputs from agencies.)