FDA-Drug2017-11-22Class III

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..

Allergan Sales, LLC
Hazard

Failed Impurities/Degradation Specifications.

Sold states
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
Affected count
715,041 bottles
Manufactured in
8301 Mars Dr, N/A, Waco, TX, United States
Products
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..

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0077-2018

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