FDAFDA · Food and drugs·Recall number D-1819-2015
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.
Published September 30, 2015 · Recall initiated: August 24, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Allergan Sales, LLC
- Distributor
- Nationwide, Puerto Rico, and Barbados
- Lot
- Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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