Drug product
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
D-1702-2012
Product summary
- Event
- Event 62885
- Status
- Terminated
- Classification
- Class II
- Quantity
- 960 bottles
- Official record key
drug-enforcement:D-1702-2012
Official wording
Reason: Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Code information: Lot ZLMM12063, Exp March 2014
Distribution pattern: The product was distributed to KY.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets