Product: 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.
Reason for recall: Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Recall initiated: 20150513
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated