USFDA Issues Recalls: Aurobindo Pharma, Glenmark Pharma, And FDC Comply

Drug makers Aurobindo Pharma, Glenmark and FDC are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration.

Aurobindo Pharma USA Inc. is recalling 240 bottles of the pain-relieving medication Healthy Living Acetaminophen, Aspirin (NSAID) and caffeine tablets due to missing labels.

This was as per the latest enforcement report of the USFDA, which said some bottles are missing the manufacturer's label.

Crucial information missing from the label included the drug facts information, according to the US-based drug regulator.

The New Jersey-based Aurobindo Pharma USA Inc. said that it initiated the Class 1 recall on July 11.

As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems.

Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling 2,404 bottles of Indomethacin Extended-Release Capsules, produced at a Madhya Pradesh plant, due to 'Failed Dissolution Specifications', the USFDA said.

Glenmark Pharmaceuticals Inc., USA, initiated the Class II recall on July 31, it added.

The USFDA report said Maharashtra-based drug maker FDC Ltd. is recalling 1,76,784 bottles of Timolol Maleate Ophthalmic Solution USP due to them having a 'Defective Container'.

Patients are unable to get the solution out of the bottle as the spike of the cap is lodged in the nozzle of the product bottle, it said.

The company initiated the Class II recall on Aug. 12 this year.

According to the USFDA, a Class II recall is issued when the use of or exposure to a non-compliant product might lead to temporary or medically reversible health effects or when the likelihood of severe health consequences is minimal.

India boasts the largest number of USFDA-compliant pharmaceutical manufacturing facilities outside of the United States.

(With Inputs From PTI)