Lupin, Dr Reddy's Labs recall products in US over manufacturing issues: USFDA

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-09-05 08:00 GMT   |   Update On 2024-09-05 08:00 GMT
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New Delhi: Pharma majors Lupin, Dr Reddy's Laboratories are recalling products in the US over manufacturing issues, according to a latest enforcement report by the US Food and Drug Administration (USFDA).

The US-based arm of the Mumbai-based drug maker Lupin is recalling the 4,554 bottles of Cefixime for Oral Suspension, used to treat bacterial infections in the market, on account of it being "Subpotent".

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According to PTI report, 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.

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.
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