Dr. Reddy’s Laboratories, through its US subsidiary, is recalling multiple strengths of morphine sulfate extended-release tablets due to manufacturing issues.
The recall, initiated on October 22, 2024, affects two different strengths of the medication, which is used for managing severe and persistent pain.
The company is recalling 2,040 bottles of the 15 mg strength due to ‘Failed Impurities/Degradation Specification’.
In addition, 532 bottles of the 30 mg strength (100-count) are being recalled for the same reason.
The recall is classified as Class II, indicating that while the product poses a risk of temporary or reversible health consequences, the likelihood of serious adverse effects is low.
The Second Company
FDC Ltd., a Mumbai-based pharmaceutical company, has also initiated a recall in the US market.
The company is recalling 1,55,232 bottles of Timolol Maleate ophthalmic solution, used to treat high pressure inside the eye caused by glaucoma.
The recall, which was launched on October 29, 2024, stems from a defect in the container design. The cap’s spike became lodged in the nozzle, making it impossible for users to dispense the solution.
Similar to Dr. Reddy’s recall, FDC’s action is classified as a Class II recall, signalling that the defective product could lead to temporary health issues, but serious harm is unlikely.
Classification of Class II Recalls
The US Food and Drug Administration (USFDA) classifies recalls based on the potential risks to consumer health.
A Class II recall occurs when exposure to the product may lead to temporary or reversible adverse health effects. However, the probability of severe health consequences is deemed remote.
Global Generic Medicine Supplier
India remains a leading player in the global generic medicine market, contributing approximately 20% of the world’s supply.
With 60,000 different generic brands across 60 therapeutic categories, Indian manufacturers export their products to over 200 countries worldwide. The key markets include the US, Japan, Australia, and Western Europe.
As reported by thehindubusinessline.com, the recent recall highlights the importance of stringent manufacturing practices in ensuring the safety of medications exported globally.
