Drug product
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
D-0693-2018
Product summary
- Event
- Event 79349
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0693-2018
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) C140C, exp 2/18; b) D049C, D050C, D051C, C142C, C137C, C138C, C141C, exp 2/18; D073C, D074C, exp 3/18
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations