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 #: 113312Exp 11/2015014315 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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