Recalls / Class III
Class IIID-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..
- Brand name
- Combigan
- Generic name
- Brimonidine Tartrate, Timolol Maleate
- Active ingredients
- Brimonidine Tartrate, Timolol Maleate
- Route
- Ophthalmic
- NDC
- 0023-9211
- FDA application
- NDA021398
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications.
Recalling firm
- Firm
- Allergan Sales, LLC
- Manufacturer
- Allergan, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8301 Mars Dr, N/A, Waco, Texas 76712-6578
Distribution
- Quantity
- 715,041 bottles
- Distribution pattern
- Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
Timeline
- Recall initiated
- 2017-10-19
- FDA classified
- 2017-11-13
- Posted by FDA
- 2017-11-22
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0077-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.