Drug product
BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9.
D-1820-2015
Product summary
- Event
- Event 72016
- Status
- Terminated
- Classification
- Class II
- Quantity
- 337 tubes
- Official record key
drug-enforcement:D-1820-2015
Official wording
Reason: 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.
Code information: Lot #: 86430, Exp 09/17; 87806, Exp 02/18; 88147, Exp 03/18
Distribution pattern: Nationwide, Puerto Rico, and Barbados
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter