FDA recall D-1838-2019

Ucb, Inc · Class II · drug

Product

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

TN

Key facts

Status
Terminated
Initiation date
2019-07-18
Report date
2019-07-31
Termination date
2020-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Smyrna, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1838-2019