Dr Reddy’s, Lupin recall products in US due to manufacturing issues, ET HealthWorld

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Dr Reddy’s, Lupin recall products in US due to manufacturing issues, ET HealthWorld

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New Delhi: Dr Reddy’s Laboratories and Lupin are recalling products in the US due to manufacturing issues, as per the US Food and ***** Administration (USFDA). Dr Reddy’s Laboratories Inc, a subsidiary of Hyderabad-based ***** 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 1,03,298 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 “******* 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 ***** Suspension in the market.

The US-based arm of the Mumbai-based ***** maker is recalling the affected lot of the *****, 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.

• Published On Sep 4, 2024 at 05:18 PM IST

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