Drug product
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
D-0929-2017
Product summary
- Event
- Event 77143
- Status
- Terminated
- Classification
- Class II
- Quantity
- 648 units
- Official record key
drug-enforcement:D-0929-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Code information: Lot: 93802, EXP NOV 2019
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications