Recalls / Class II

Class IID-1819-2015

Product

FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.

Affected lot / code info

Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17

Why it was recalled

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Recalling firm

Firm

Allergan Sales, LLC

Notification channel

N/A

Type

Voluntary: Firm initiated

Address

8301 Mars Dr, N/A, Waco, Texas 76712-6578

Distribution

Quantity

28,292 tubes

Distribution pattern

Nationwide, Puerto Rico, and Barbados

Timeline

Recall initiated

2015-08-24

FDA classified

2015-09-22

Posted by FDA

2015-09-30

Terminated

2017-04-19

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1819-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.