March 2017 FDA Recall Lumigan by Allergan Sales, Llc
D-0667-2017 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Allergan Sales, Llc on March 16, 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.

Recall Number: D-0667-2017

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
03-16-2017
Reported
04-19-2017
Quantity
56,878 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76748
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-01-2019
Product Description About Product Description
Full technical description of the product.
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.

Batch or Lot Expiration Information

Lot# : 92577, Exp. JUN 2018

Affected Packages Involved in this Recall

0023-3205-02 Lumigan
0023-3205-03 Lumigan
0023-3205-05 Lumigan
0023-3205-08 Lumigan