Drug product
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.
D-0235-2018
Product summary
- Event
- Event 78822
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,853,500 Caplets
- Official record key
drug-enforcement:D-0235-2018
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: Lot #: HH6001, HH6002, Exp 04/18
Distribution pattern: Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations