Home / Recalls / Allergan Sales, LLC / D-0929-2017

D-0929-2017 Class II Terminated

Recalled by Allergan Sales, LLC — Waco, TX

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

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  • D-1819-2015 Class II — FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, I (August 24, 2015)