Drug product
Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
D-0690-2018
Product summary
- Event
- Event 79349
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0690-2018
Official wording
Reason: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Code information: a) D044C, D038C, D043C, exp 3/18, b) C136C, exp 3/18, D039C, D040C, D041C, D042C, 3/18
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations