- 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.
- 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 Inc by Marksans Pharma at its Goa facility, it added.
Marksans Pharma’s arm Time-Cap Laboratories Inc. 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 U.S. 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 U.S. 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 Inc 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 (U.S. FDA) said.
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As per the U.S. 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 offers contract research and manufacturing services to pharmaceutical companies.
Date: May 06, 2018
