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.
Reported: September 30, 2015 Initiated: August 24, 2015 #D-1819-2015
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Allergan Sales, LLC
- Units Affected
- 28,292 tubes
- Distribution
- Nationwide, Puerto Rico, and Barbados
- Location
- Waco, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Allergan Sales, LLC. Units affected: 28,292 tubes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 30, 2015. Severity: Moderate. Recall number: D-1819-2015.
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