Drug 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.
D-0420-2015
Product summary
- Event
- Event 70548
- Status
- Terminated
- Classification
- Class III
- Quantity
- 445,475 Vials
- Official record key
drug-enforcement:D-0420-2015
Official wording
Reason: Failed Impurities/Degradation Specifications; 12 month stability testing.
Code information: Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications