FDAFDA · Food and drugs·Recall number D-1139-2015
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
Published June 24, 2015 · Recall initiated: May 13, 2015
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; 12 month stability testing (Expansion of RES #70548).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FENTANYL CITRATE
- Manufacturer
- West-Ward Pharmaceutical Corp.
- Distributor
- Nationwide
- Lot
- Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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