PlainRecalls
FDA Drug Moderate Class II Terminated

Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0591-2021

Product Description

Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
101 bottles
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66. Recalled by Cardinal Health Inc.. Units affected: 101 bottles.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0591-2021.