March 2019 FDA Recall Combigan by Allergan Sales, Llc
D-1056-2019 - cGMP Deviations
This Class II drug recall was voluntarily initiated by Allergan Sales, Llc on March 19, 2019 for the product Combigan. The FDA reported the reason for recall as cgmp deviations. The product was distributed in TN only and the recall is currently terminated.
Recall Number: D-1056-2019
cGMP Deviations
03-19-2019
04-03-2019
72 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.
Allergan Sales, LLC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TN only
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
Batch or Lot Expiration Information
Lot# : 99946 Exp. January 16, 2021
