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Class III: unlikely to cause harmTerminated

Allergan Sales Lumigan Recall

Lumigan (bimatoprost ophthalmic solution) 0

Allergan Sales, LLC · Waco, TX

Risk level
Class III
Reported by FDA
Nov 22, 2017
Recall ID
D-0078-2018
Check your lot numberHow we source this data

Summary

Allergan Sales recalled Lumigan starting Oct 19, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0078-2018 on Nov 22, 2017. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications.

Product description

Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03

Lot numbers, UPCs & expiration codes

Lot #: 92575 Exp. JUN-2018

Where it was sold

Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0078-2018
Classification
Class III
Status
Terminated
Recall initiated
Oct 19, 2017
FDA report date
Nov 22, 2017
Quantity
153,616 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Allergan Sales, LLC

Original FDA data

Every field from FDA enforcement report D-0078-2018, exactly as published.

Show all FDA fields
City
Waco
State
TX
Status
Terminated
Country
United States
Event ID
78325
Address
8301 Mars Dr
Code information
Lot #: 92575 Exp. JUN-2018
Postal code
76712-6578
Report date
Nov 22, 2017
Product type
Drugs
Recall number
D-0078-2018
Classification
Class III
Recalling firm
Allergan Sales, LLC
Product quantity
153,616 bottles
Termination date
Oct 30, 2019
Reason for recall
Failed Impurities/Degradation Specifications.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Distribution pattern
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
Recall initiation date
Oct 19, 2017
Initial firm notification
Letter
Center classification date
Nov 13, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0078-2018, published Nov 22, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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