Dr Reddy's, Lupin recall products in US due to manufacturing issues: USFDA

Dr Reddy's Laboratories and Lupin are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA).

Dr Reddy's Laboratories Inc, a subsidiary of Hyderabad-based drug firm, is recalling Ibuprofen tablets in multiple strengths, the US health regulator said in its latest enforcement report.

Ibuprofen tablets are indicated for pain relief and fever.

New Jersey-based Dr Reddy's Laboratories Inc. is recalling 103,298 bottles (800 mg); 31,802 bottles (600 mg); and 14,940 bottles (400 mg) of Ibuprofen tablets in the US market, USFDA said.

The company is recalling the affected lot due to "Failed impurities/degradation specifications," it added.

"Results for unknown impurity were 0.13 per cent and 0.11 per cent, respectively, exceeding the 0.10 per cent specification limit," USFDA noted.

The company initiated the Class II nationwide recall on August 6 this year.

USFDA stated that Lupin is recalling 4,554 bottles of Cefixime for Oral Suspension in the market.

The US-based arm of the Mumbai-based drug maker is recalling the affected lot of the drug, used to treat bacterial infections, on account of it being "Subpotent".

Baltimore-based Lupin Pharmaceuticals Inc. initiated the Class II recall on August 21.

As per the USFDA, a Class II recall is initiated in a situation in which the 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.