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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17
Where it was sold
Nationwide, Puerto Rico, and Barbados
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-1819-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2015
- FDA report date
- Sep 30, 2015
- Quantity
- 28,292 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan Sales, LLC
Original FDA data
Every field from FDA enforcement report D-1819-2015, exactly as published.
Show all FDA fields
- City
- Waco
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 72016
- Address
- 8301 Mars Dr
- Code information
- Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17
- Postal code
- 76712-6578
- Report date
- Sep 30, 2015
- Product type
- Drugs
- Recall number
- D-1819-2015
- Classification
- Class II
- Recalling firm
- Allergan Sales, LLC
- Product quantity
- 28,292 tubes
- Termination date
- Apr 19, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide, Puerto Rico, and Barbados
- Recall initiation date
- Aug 24, 2015
- Center classification date
- Sep 22, 2015