D-1819-2015 Class II Terminated
FDA drug recall D-1819-2015 was initiated by Allergan Sales, LLC on Aug 24, 2015 and is designated Class II. 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… The recall status is terminated (terminated Apr 19, 2017). Affected quantity: 28,292 tubes.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 30, 2015
- Initiation Date
- Aug 24, 2015
- Termination Date
- Apr 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,292 tubes
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.
Distribution pattern
Nationwide, Puerto Rico, and Barbados
Code information
Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1819-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026