Drug recall D-0694-2018
Product
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
Reason for recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Lots and codes
a) F066C b) F066C c) F066C
Recall details
- Recalling firm
- Time-Cap Laboratories, Inc., Farmingdale, NY
- Quantity
- N/A
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 11, 2018
- Terminated
- January 20, 2021
Related products
- Ibuprofen – drug information
- NDC 49483-600 Ibuprofen · Ibuprofen 200 mg/1 · TIME CAP LABORATORIES,INC
- NDC 49483-601 Ibuprofen · Ibuprofen 200 mg/1 · TIME CAP LABORATORIES,INC
- NDC 49483-114 Ibuprofen · Ibuprofen 200 mg/1 · TIME CAP LABORATORIES,INC