FDAFDA · Food and drugs·Recall number D-0688-2018
Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
Published May 2, 2018 · Recall initiated: January 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Time-Cap Laboratories, Inc.
- Distributor
- Nationwide.
- Lot
- C128C, C129C, exp 3/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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