Drug product
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50
D-1055-2017
Product summary
- Event
- Event 77576
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,980 bottles
- Official record key
drug-enforcement:D-1055-2017
Official wording
Reason: Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Code information: Lot #: HN7003
Distribution pattern: Nationwide U.S.A.
Derived failure modes
-
Foreign material or chemical contamination
foreign tablets