Class III
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 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
- Company
- West-Ward Pharmaceutical Corp.
- Recall Initiated
- May 13, 2015
- Posted
- June 24, 2015
- Recall Number
- D-1139-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,649 Cartons
- Firm Location
- Eatontown, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Distribution
Nationwide
Lot / Code Info
Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015
More recalls by West-Ward Pharmaceutical Corp.
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Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Ea...
Dec 25, 2013 · Class II
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