Multi-event October 2017 FDA Recall Lumigan by Allergan Sales, Llc
This Multi-event Class III drug recall was voluntarily initiated by Allergan Sales, Llc on October 19, 2017 for the product Lumigan. The FDA reported the reason for recall as failed impurities/degradation specifications.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0078-2018
Failed Impurities/Degradation Specifications.
10-19-2017
11-22-2017
153,616 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Allergan Sales, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
10-30-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Batch or Lot Expiration Information
Lot# : 92575 Exp. JUN-2018
Affected Packages Involved in this Recall
Recall Number: D-0077-2018
Failed Impurities/Degradation Specifications.
10-19-2017
11-22-2017
715,041 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Allergan Sales, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
10-30-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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..
Batch or Lot Expiration 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
