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Recall Observatory FDA recall evidence

Drug product

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..

D-0077-2018

October 19, 2017

Class III

Product summary

Firm
Allergan Sales, LLC
Event
Event 78325
Status
Terminated
Classification
Class III
Quantity
715,041 bottles
Official record key
drug-enforcement:D-0077-2018

Official wording

Reason: Failed Impurities/Degradation Specifications.

Code information: Lot #: a) 94659 Exp. FEB-2019; b) 94715, Exp. JAN-2019; 94757, Exp. FEB-2019, 94715A, Exp. JAN-2019; 95297, Exp. MAR-2019; c) 95223 Exp. MAR-2019; d) 95220 Exp. MAR-2019

Distribution pattern: Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications