Reported Apr 1, 2015 · Terminated

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…

West-Ward Pharmaceutical Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: West-Ward Pharmaceutical Corporation · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002

Is this the product you have?

  • 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 byWest-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25
Lot codes and dates
    • Lot #: 113312
    • Exp 11/2015
    • 014315 Exp 01/2016
Amount recalled
445,475 Vials

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications; 12 month stability testing.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 26, 2016 · Data as of Sep 19, 6:34 PM UTC

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