According to the US FDA, the nationwide, voluntary and ongoing recall is a Class II recall
Marksans Pharmas arm Time-Cap Laboratories is withdrawing unspecified number of Ibuprofen tablets, manufactured in Goa, in multiple strengths from the American market on account of deviation from the good manufacturing norms, according to the latest US FDA report.
The reason for recall is ‘CGMP Deviations: various strengths of Ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies,’ latest enforcement report of the US health regulator said.
The tablets in the strengths of 200mg, 400 mg, 600 mg and 800 mg and caplets in the strength 200 mg were manufactured for Time Cap Labs by Marksans Pharma at its Goa facility, it added.
The nationwide, voluntary and ongoing recall by Time-Cap Laboratories, Inc is a Class II recall, the United States Food and Drug Administration (US FDA) said.
As per the US FDA, 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.”
Ibuprofen is a nonsteroidal anti-inflammatory drug used for treating pain.
Headquartered at Mumbai, Marksans Pharma is a global pharma major which offers contract research and manufacturing services (CRAMS) to pharmaceutical companies.