FDA Drug Class II — Moderate

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped 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 25000-117-30.

Hazard

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

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Products

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-8
Brand
Marksans Pharma Inc.
UPC
Lot #: HH6001, HH6002, Exp 04/18

Units Affected

2,853,500 Caplets

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