FDA Drug Class II — Moderate

Ibuprofen Tablets, USP 600 mg, 6 x 2500 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 25000-122-28.

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 600 mg, 6 x 2500 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. Esta
Brand
Marksans Pharma Inc.
UPC
Lot #: HN6004, HN6005, HN6006, HN6007, HN6008, HN6009, HN6010, HN6011, HN6012, HN6013, HN6014, Exp 03/18; HN6015, HN6016, HN6017, HN6018, HN6019, HN6020, HN6021, HN6022, HN6023, Exp 04/18; HN6024, Exp 07/18; HN6025, HN6026, HN6027, Exp 09/18

Units Affected

23,088,900 tablets

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