Recalls / Class II
Class IID-1056-2019
Product
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
- 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#: 99946 Exp. January 16, 2021
Why it was recalled
cGMP Deviations
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
- 72 bottles
- Distribution pattern
- TN only
Timeline
- Recall initiated
- 2019-03-19
- FDA classified
- 2019-03-22
- Posted by FDA
- 2019-04-03
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1056-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.