D-0109-2021 Class II Terminated
FDA drug recall D-0109-2021 was initiated by EYWA PHARMA INC on November 10, 2020 and is designated Class II. Reason for recall: Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets. The recall status is terminated (terminated October 16, 2024). Affected quantity: 5451 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 2, 2020
- Initiation Date
- November 10, 2020
- Termination Date
- October 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5451 bottles
Product Description
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
Reason for Recall
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Distribution Pattern
USA Nationwide
Code Information
Lot #: LEV5019021A, Exp 10/2021