Marksans Pharma Inc. recalls Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx on
Recalled January 31, 2018 · FDA recall D-0238-2018 · Marksans Pharma
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
21,584,100 tablets
Sold at
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
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 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29.
Manufacturer(s)
Marksans Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →