FDAFDA · Food and drugs·Recall number D-0691-2018
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, 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
- Manufacturer
- Time-Cap Laboratories, Inc.
- Distributor
- Nationwide.
- Lot
- a) C135C, exp 3/18 b) C134C, exp 3/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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