Dr Reddy’s Laboratories and FDC Ltd are recalling generic drugs from the US market due to manufacturing problems, according to the US health regulator. According to a recent report by the US Food and Drug Administration (USFDA), a subsidiary of Dr Reddy’s Laboratories in the US is recalling high strength Morphine Sulfate extended release tablets in the US. The drug is used to relieve severe and chronic pain.
According to the USFDA, Princeton-based Dr Reddy’s Laboratories Inc is recalling 2,040 bottles of long-release 15 mg Morphine Sulfate tablets due to “Failed Impurity Specification/Deterioration”.
The drugmaker is also recalling another 532,100 bottles of the drug in the 30 mg strength for the same reason, the USFDA said.
Dr Reddy’s began a Class II nationwide recall on October 22 this year.
The USFDA said Mumbai-headquartered FDC Ltd is recalling 1,55,232 bottles of Timolol Maleate ophthalmic solution from the US market.
The company is recalling the affected lot due to “Defective Container: Could not dispense the solution from the bottle as the tip of the cap was inserted into the mouth of the product bottle”, the US health regulator said.
The company began the Class II recall on October 29, 2024.
Timolol Maleate ophthalmic solution is used to treat high pressure inside the eye due to glaucoma.
According to the USFDA, a Phase II recall is initiated in a situation where the use of, or exposure to, the offending product may cause temporary or reversible health effects or where the likelihood of adverse health effects is remote.
India is the largest supplier of generic drugs with a 20 percent share in global supply by producing 60,000 different types of generic drugs in 60 therapeutic areas.
Products produced in this country are exported to more than 200 countries around the world, with Japan, Australia, Western Europe, and the US as the main destinations.
