Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Fentanyl Citrate (Sublimaze) Injection
Status: Currently in Shortage
»Date first posted:
No date available
»Therapeutic Categories: Analgesia/Addiction; Pediatric
Akorn Pharmaceuticals (Revised 03/01/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 2 mL ampule 10 pack (NDC 17478-0030-02) | Not available | No new manufacturing of product | |
| 2 mL ampule; 25 pack (NDC 17478-0030-25) | Not available | No new manufacturing of product | |
| 5 mL ampule 10 pack (NDC 17478-0030-05) | Not available | No new manufacturing of product | |
| 20 mL ampule (NDC 17478-0030-20) | Not available | No new manufacturing of product | |
| 5 mL ampule 25 pack (NDC 17478-0030-55) | Not available | No new manufacturing of product |
Fresenius Kabi USA (Reverified 05/31/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1,000 mcg per 20 mL (50 mcg per mL) (0.05 mg per mL) SDV (NDC 63323-806-20) | Available | Check wholesalers for inventory | Increase in demand |
| 2,500 mcg per 50 mL (50 mcg per mL) (0.05 mg per mL) SDV (NDC 63323-806-50) | Backordered. Next release not available at this time. | Check wholesalers for inventory | Increase in demand |
| 50 mcg per 1 mL (50 mcg per mL) (0.05 mg per mL) SDV (NDC 63323-806-01) | Available | Check wholesalers for inventory | Increase in demand |
| 100 mcg per 2 mL (50 mcg per mL) (0.05 mg per mL) SDV (NDC 63323-806-02) | Available | Check wholesalers for inventory | Increase in demand |
| 250 mcg per 5 mL (50 mcg per mL) (0.05 mg per mL) SDV (NDC 63323-806-05) | Available | Check wholesalers for inventory | Increase in demand |
| 50 mcg per 1 mL (50 mcg per mL) Single Dose Simplist PFS (NDC 63323-808-11) | Available | Check wholesalers for inventory | Increase in demand |
Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 05/16/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 50 mcg/mL 2 mL ampul (NDC 0641-6024-10) | Unavailable | Inventory available in vial presentations. | Demand increase for the drug |
| 50 mcg/mL 5 mL ampul (NDC 0641-6025-10) | Unavailable | Inventory available in vial presentations. | Demand increase for the drug |
| 50 mcg/mL 20 mL ampul (NDC 0641-6026-05) | Currently not available | Inventory available in vial presentations. | Demand increase for the drug |
| 50 mcg/mL 2 mL vial(NDC 0641-6027-25) | Available | Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. | Demand increase for the drug |
| 50 mcg/mL 5 mL vial(NDC 0641-6028-25) | Available | Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. | Demand increase for the drug |
| 50 mcg/mL 20 mL vial (NDC 0641-6029-25) | Available | Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. | Demand increase for the drug |
| 50 mcg/mL 50 mL vial(NDC 0641-6030-01) | Available | Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. | Demand increase for the drug |
| 50 mcg/mL 1 mL vial(NDC 0641-6247-25) | Inventory is currently available. | Additional lots will be scheduled for manufacturing to meet demand. Product will be made available as it is released. | Demand increase for the drug |
Hospira, Inc., a Pfizer company (Revised 05/15/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 100 mcg/2 mL (50 mcg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1276-32) | Next Delivery: February 2025; Estimated Recovery: March 2025 | Shortage per Manufacturer: Manufacturing Delay
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |
| 100 mcg/2 mL (50 mcg/mL); Glass Ampul (NDC 00409-9093-32) | Limited Supply Available. Next Delivery: January 2024; Estimated Recovery: March 2024 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |
| 250 mcg/5 mL (50 mcg/mL); Glass Ampul (NDC 00409-9093-35) | Next Delivery: February 2024; Estimated Recovery: March 2024 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |
| 100 mcg/2 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-22) | Limited Supply Available. Next Delivery: May 2023; Estimated Recovery: June 2024 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |
| 250 mcg/5 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-25) | Limited Supply Available. Next Delivery: May 2023; Estimated Recovery: June 2023 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |
| 500 mcg/10 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-28) | Available |
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |
| 1,000 mcg/20 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-31) | Limited Supply Available. Next Delivery: May 2023; Estimated Recovery: September 2023 | Shortage per Manufacturer: Manufacturing Delay
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |
| 2,500 mcg/50 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-61) | Available |
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |