D-1838-2019 Class II Terminated
FDA drug recall D-1838-2019 was initiated by Ucb, Inc on July 18, 2019 and is designated Class II. Reason for recall: Failed Dissolution Specifications. The recall status is terminated (terminated January 24, 2020). Affected quantity: 2088 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- July 18, 2019
- Termination Date
- January 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2088 bottles
Product Description
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
Reason for Recall
Failed Dissolution Specifications.
Distribution Pattern
TN
Code Information
Lot: 908946 Exp. 02/2022