Drug product
Ibuprofen Tablets, USP 400 mg, 6 x 3500 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 25000-121-29.
D-0238-2018
Product summary
- Event
- Event 78822
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,584,100 tablets
- Official record key
drug-enforcement:D-0238-2018
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 #: HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, HK6015, Exp 09/18
Distribution pattern: Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations