D-0077-2018 Class III Terminated
FDA drug recall D-0077-2018 was initiated by Allergan Sales, LLC on Oct 19, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications. The recall status is terminated (terminated Oct 30, 2019). Affected quantity: 715,041 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 22, 2017
- Initiation Date
- Oct 19, 2017
- Termination Date
- Oct 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 715,041 bottles
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.
Distribution pattern
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0077-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026