Major Pharma Companies Initiate Recalls Due to Manufacturing Issues

Drug makers Aurobindo Pharma, Glenmark, and FDC are recalling products in the US due to manufacturing issues. The USFDA has classified these recalls into Class I and Class II categories, highlighting potential serious health risks. The recalls involve pain-relieving medication, extended-release capsules, and ophthalmic solution.


Devdiscourse News Desk | New Delhi | Updated: 26-08-2024 19:03 IST | Created: 26-08-2024 19:03 IST
Major Pharma Companies Initiate Recalls Due to Manufacturing Issues
This image is AI-generated and does not depict any real-life event or location. It is a fictional representation created for illustrative purposes only.
  • Country:
  • India

Pharmaceutical giants Aurobindo Pharma, Glenmark, and FDC are facing recalls in the United States due to various manufacturing issues, according to the US Food and Drug Administration (USFDA).

Aurobindo Pharma USA Inc, a subsidiary of the Hyderabad-based drug major, initiated a Class I recall on July 11 for 240 bottles of Healthy Living Acetaminophen, Aspirin (NSAID), and caffeine tablets due to missing labels, which include critical drug facts information.

Similarly, Glenmark Pharmaceuticals Inc USA is recalling 2,404 bottles of Indomethacin Extended-Release Capsules produced at a Madhya Pradesh plant for failing dissolution specifications. FDC Ltd is recalling 176,784 bottles of Timolol Maleate Ophthalmic Solution USP due to defective containers that prevent patients from using the product. These recalls highlight the stringent regulatory environment and the potential health risks associated with defective pharmaceutical products.

(With inputs from agencies.)

Give Feedback