Drug product
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
D-0223-2018
Product summary
- Event
- Event 78821
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0223-2018
Official wording
Reason: Presence of foreign substance: metallic razor blade was found in one bottle.
Code information: Lot #: E171280, Exp 06/19
Distribution pattern: U.S.A. nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance