Recalls / Class II
Class IID-1838-2019
Product
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
- Brand name
- Keppra
- Generic name
- Levetiracetam
- Active ingredient
- Levetiracetam
- Route
- Oral
- NDCs
- 50474-001, 50474-594, 50474-595, 50474-596, 50474-597
- FDA application
- NDA021505
- Affected lot / code info
- Lot: 908946 Exp. 02/2022
Why it was recalled
Failed Dissolution Specifications.
Recalling firm
- Firm
- Ucb, Inc
- Manufacturer
- UCB, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1950 Lake Park Dr Se, N/A, Smyrna, Georgia 30080-7648
Distribution
- Quantity
- 2088 bottles
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2019-07-18
- FDA classified
- 2019-08-21
- Posted by FDA
- 2019-07-31
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1838-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.