Recalls / Class II
Class IID-0929-2017
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.
- Affected lot / code info
- Lot: 93802, EXP NOV 2019
Why it was recalled
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Recalling firm
- Firm
- Allergan Sales, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8301 Mars Dr, N/A, Waco, Texas 76712-6578
Distribution
- Quantity
- 648 units
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2017-05-01
- FDA classified
- 2017-06-29
- Posted by FDA
- 2017-07-05
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0929-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.