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.
Reported: June 24, 2015 Initiated: May 13, 2015 #D-1139-2015
Product Description
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).
Details
- Recalling Firm
- West-Ward Pharmaceutical Corp.
- Units Affected
- 14,649 Cartons
- Distribution
- Nationwide
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by West-Ward Pharmaceutical Corp.. Units affected: 14,649 Cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 24, 2015. Severity: Low. Recall number: D-1139-2015.
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