FDA recall D-0077-2018

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..

Reason for recall

Failed Impurities/Degradation Specifications.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-10-19

Report date

2017-11-22

Termination date

2019-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waco, TX, United States

Primary source

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