Aurobindo, others recall products in US market over production issue: USFDA

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 (USFDA).

Aurobindo Pharma USA Inc -- a unit of Hyderabad-based drug major -- is recalling 240 bottles of pain-relieving medication Healthy Living Acetaminophen, Aspirin (NSAID) and caffeine tablets.

As per the latest enforcement report of USFDA, the company is recalling the affected lot due to "Missing Label".

Some bottles are missing the manufacturer's label that includes the drug facts information, the US health regulator said.

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

 

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", USFDA said.

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

USFDA report said Maharashtra-based drug maker FDC Ltd is recalling 176,784 bottles of Timolol Maleate Ophthalmic Solution USP due to "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 August 12 this year.

As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.