FDA Recall Fentanyl Citrate
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Fentanyl Citrate with NDC 0641-6248 was initiated on 05-13-2015 as a Class III recall due to failed impurities/degradation specifications; 12 month stability testing (expansion of res #70548). The latest recall number for this product is D-1139-2015 and the recall is currently terminated as of 04-06-2016 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-1139-2015 | 05-13-2015 | 06-24-2015 | Class III | 14,649 Cartons | 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. | Terminated |
| D-0420-2015 | 02-16-2015 | 04-01-2015 | Class III | 445,475 Vials | 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. | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.