Product: 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.
Reason for recall: Failed Impurities/Degradation Specifications; 12 month stability testing.
Recall initiated: 20150216
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated