July 2019 FDA Recall Keppra by Ucb, Inc
D-1838-2019 - Failed Dissolution Specifications.
This Class II drug recall was voluntarily initiated by Ucb, Inc on July 18, 2019 for the product Keppra. The FDA reported the reason for recall as failed dissolution specifications.. The product was distributed in TN and the recall is currently terminated.
Recall Number: D-1838-2019
Failed Dissolution Specifications.
07-18-2019
07-31-2019
2088 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ucb, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TN
01-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
Batch or Lot Expiration Information
Lot# Lot: 908946 Exp. 02/2022
