Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged ...
FDA Recall #D-0077-2018 — Class III — October 19, 2017
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.
Recalling Firm
Allergan Sales, LLC — Waco, TX
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
715,041 bottles
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated