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Recall of Ibuprofen tablets from US by Marksans Pharma on account of cGMP violations

Marksans Pharma's is a global pharmaceutical company headquartered in Mumbai which offers contract research and manufacturing services to other pharmaceutical companies. It’s subsidiary Time-Cap Laboratories Inc is withdrawing unspecified number of Ibuprofen tablets, manufactured in Goa from US market on account of cGMP (Good Manufacturing Practices) violations.

According to USFDA regulator, "various strengths of Ibuprofen tablets (200mg, 400 mg, 600 mg and 800 mg)/caplets(200 mg) manufactured for Time Cap Labs Inc by Marksans Pharma at its Goa facility" are being recalled due to complaints of odor related to CGMP deficiencies. Ibuprofen is a nonsteroidal anti-inflammatory drug used for treating pain.

The recall is a class II recall which according to USFDA 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."