Class III
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 Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
This recall has been terminated (originally issued April 1, 2015).
- Recall Initiated
- February 16, 2015
- Posted
- April 1, 2015
- Recall Number
- D-0420-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 445,475 Vials
- Firm Location
- Cherry Hill, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications; 12 month stability testing.
Distribution
Nationwide
Lot / Code Info
Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016
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