FML (fluorometholone ophthalmic ointment) 0.1% recall: Particulate Matter
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.
Why was FML (fluorometholone ophthalmic ointment) 0.1% 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17
- 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.
- Recalling firm
- Allergan Sales, LLC
- Quantity
- 28,292 tubes
- Distribution
- Nationwide, Puerto Rico, and Barbados
- Recall date
- September 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)