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Recall Observatory FDA recall evidence

Drug 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

D-1056-2019

March 19, 2019

Class II

Product summary

Firm
Allergan Sales, LLC
Event
Event 82424
Status
Terminated
Classification
Class II
Quantity
72 bottles
Official record key
drug-enforcement:D-1056-2019

Official wording

Reason: cGMP Deviations

Code information: Lot#: 99946 Exp. January 16, 2021

Distribution pattern: TN only

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations