West-Ward Pharmaceutical Corp. recalls 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
Recalled June 24, 2015 · FDA recall D-1139-2015 · West-Ward Pharmaceutical
Hazard
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). · FDA Class III
Units
14,649 Cartons
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Product
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.
Manufacturer(s)
West-Ward Pharmaceutical Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →