Recalls / Class III
Class IIID-0667-2017
Product
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
- Brand name
- Lumigan
- Generic name
- Bimatoprost
- Active ingredient
- Bimatoprost
- Route
- Ophthalmic
- NDC
- 0023-3205
- FDA application
- NDA022184
- Affected lot / code info
- Lot #: 92577, Exp. JUN 2018
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Allergan Sales, LLC
- Manufacturer
- Allergan, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8301 Mars Dr, N/A, Waco, Texas 76712-6578
Distribution
- Quantity
- 56,878 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2017-03-16
- FDA classified
- 2017-04-12
- Posted by FDA
- 2017-04-19
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0667-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.