Drug product
Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52
D-0109-2021
Product summary
- Firm
- EYWA PHARMA INC
- Event
- Event 86740
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5451 bottles
- Official record key
drug-enforcement:D-0109-2021
Official wording
Reason: Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Code information: Lot #: LEV5019021A, Exp 10/2021
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablet