Drug product
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
D-0691-2018
Product summary
- Event
- Event 79349
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0691-2018
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) C135C, exp 3/18 b) C134C, exp 3/18
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations