FDAFDA · Food and drugs·Recall number D-0686-2018
Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
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
- Brand
- IBUPROFEN
- Manufacturer
- Time-Cap Laboratories, Inc.
- Distributor
- Nationwide.
- UPC
- 0093351027697
- Lot
- a) D167C, exp 2/18, E135C, exp 3/18; b) D172C, exp 2/18; c) D167C, exp 2/18, E135C, exp 3/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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