FDA-Drug2015-04-01Class III
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
West-Ward Pharmaceutical Corporation
Hazard
Failed Impurities/Degradation Specifications; 12 month stability testing.
Sold states
Nationwide
Affected count
445,475 Vials
Manufactured in
2 Esterbrook Ln, Cherry Hill, NJ, United States
Products
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0420-2015Don't want to check this manually?
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