Recalls / Class III
Class IIID-0078-2018
Product
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
- Brand name
- Lumigan
- Generic name
- Bimatoprost
- Active ingredient
- Bimatoprost
- Route
- Ophthalmic
- NDC
- 0023-3205
- FDA application
- NDA022184
- Affected lot / code info
- Lot #: 92575 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
- 153,616 bottles
- Distribution pattern
- Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
Timeline
- Recall initiated
- 2017-10-19
- FDA classified
- 2017-11-13
- Posted by FDA
- 2017-11-22
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0078-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.