Drug 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..
D-0077-2018
Product summary
- Event
- Event 78325
- Status
- Terminated
- Classification
- Class III
- Quantity
- 715,041 bottles
- Official record key
drug-enforcement:D-0077-2018
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: 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
Distribution pattern: Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications