Reported Jun 24, 2015 · Terminated
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…
West-Ward Pharmaceutical Corp.
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 Corp. · 465 Industrial Way W · Eatontown, NJ · 07724-2209
Is this the product you have?
- 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 byWest-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25
- Lot codes and dates
Lot #: 043410Exp 04/2015053391Exp 05/2015073340Exp 07/2015083330083333083335Exp 08/2015093319093321093323Exp 09/2015103316103318Exp 10/2015
- Amount recalled
- 14,649 Cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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