Drug product
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
D-0583-2018
Product summary
- Event
- Event 79361
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bottles
- Official record key
drug-enforcement:D-0583-2018
Official wording
Reason: CGMP deviations: Ibuprofen is being recalled in response to previous recall
Code information: Lot#: HJ6138
Distribution pattern: NY
Derived failure modes
-
Manufacturing or process control
CGMP deviations