FDAFDA · Food and drugs·Recall number D-0694-2018
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., 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
- Brand
- IBUPROFEN
- Manufacturer
- Time-Cap Laboratories, Inc.
- Distributor
- Nationwide.
- UPC
- 0349483600018
- Lot
- a) F066C b) F066C c) F066C
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.