Why it was recalled
Failed Dissolution Specifications.
Product description
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
Lot numbers, UPCs & expiration codes
Lot: 908946 Exp. 02/2022
Where it was sold
TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1838-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 2088 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ucb, Inc
Original FDA data
Every field from FDA enforcement report D-1838-2019, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 83368
- Address
- 1950 Lake Park Dr Se
- Code information
- Lot: 908946 Exp. 02/2022
- Postal code
- 30080-7648
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1838-2019
- Classification
- Class II
- Recalling firm
- Ucb, Inc
- Product quantity
- 2088 bottles
- Termination date
- Jan 24, 2020
- Reason for recall
- Failed Dissolution Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
- Distribution pattern
- TN
- Recall initiation date
- Jul 18, 2019
- Initial firm notification
- Telephone
- Center classification date
- Aug 21, 2019