FDA recall D-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.

Reason for recall

Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2017-05-01

Report date

2017-07-05

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waco, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0929-2017