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
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0929-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026