FDA-Drug2015-06-24Class III
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.
West-Ward Pharmaceutical Corp.
Hazard
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Sold states
Nationwide
Affected count
14,649 Cartons
Manufactured in
465 Industrial Way W, Eatontown, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1139-2015Don't want to check this manually?
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