FDAFDA · Food and drugs·Recall number D-0929-2017
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.
Published July 5, 2017 · Recall initiated: May 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Allergan Sales, LLC
- Distributor
- Nationwide in the US
- Lot
- Lot: 93802, EXP NOV 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.