Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distrib
Recalled May 2, 2018 · FDA recall D-0693-2018 · Time-Cap Laboratories
Hazard
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. · FDA Class II
Units
N/A
Sold at
Nationwide.
Description
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Product
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Manufacturer(s)
Time-Cap Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →