Drug recall D-0687-2018
Product
Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate 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) M104C, exp 9/18, L016C, H092C, and H093C, exp 9/18 b) C128C, C129C, C130C, C132C, exp 3/18, HK6011, exp 7/18, L016C and H092C, exp 9/18,
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 49483-602 Ibuprofen · Ibuprofen 400 mg/1 · TIME CAP LABORATORIES, INC
- NDC 49483-603 Ibuprofen · Ibuprofen 600 mg/1 · TIME CAP LABORATORIES, INC
- NDC 49483-604 Ibuprofen · Ibuprofen 800 mg/1 · TIME CAP LABORATORIES, INC