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..
Reported: November 22, 2017 Initiated: October 19, 2017 #D-0077-2018
Product Description
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.
Details
- Recalling Firm
- Allergan Sales, LLC
- Units Affected
- 715,041 bottles
- Distribution
- Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
- Location
- Waco, TX
Frequently Asked Questions
What product was recalled? ▼
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... Recalled by Allergan Sales, LLC. Units affected: 715,041 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 22, 2017. Severity: Low. Recall number: D-0077-2018.
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