D-0929-2017 Class II Terminated
FDA drug recall D-0929-2017 was initiated by Allergan Sales, LLC on May 1, 2017 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities. The recall status is terminated (terminated May 1, 2019). Affected quantity: 648 units.
Recall Details
- Product Type
- Drugs
- Report Date
- July 5, 2017
- Initiation Date
- May 1, 2017
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 648 units
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Distribution Pattern
Nationwide in the US
Code Information
Lot: 93802, EXP NOV 2019