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FDA Drug Shortages

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

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Akorn Pharmaceuticals (Revised 02/12/2021)

Company Contact Information:
800-932-5676

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mL ampule 10 pack (NDC 17478-0030-02) Available Other
2 mL ampule; 25 pack (NDC 17478-0030-25) Discontinued
5 mL ampule 10 pack (NDC 17478-0030-05) Available Other
20 mL ampule (NDC 17478-0030-20) Discontinued
5 mL ampule 25 pack (NDC 17478-0030-55) Discontinued

Fresenius Kabi USA, LLC (Revised 09/14/2022)

Company Contact Information:
888-386-1300

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) Backordered. Next release September 2022. 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) Available 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) Backordered. Next release not available at this time. 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 04/08/2022)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mcg/mL 2 mL ampul (NDC 0641-6024-10) Currently not available Demand increase for the drug
50 mcg/mL 5 mL ampul (NDC 0641-6025-10) Currently not available Demand increase for the drug
50 mcg/mL 20 mL ampul (NDC 0641-6026-05) Currently not available Demand increase for the drug
50 mcg/mL 2 mL vial (NDC 0641-6027-25) Inventory is currently available. Demand increase for the drug
50 mcg/mL 5 mL vial (NDC 0641-6028-25) This presentation is temporarily on backorder. Demand increase for the drug
50 mcg/mL 20 mL vial (NDC 0641-6029-25) This presentation is temporarily on backorder. Demand increase for the drug
50 mcg/mL 50 mL vial (NDC 0641-6030-01) Inventory is currently available. Demand increase for the drug
50 mcg/mL 1 mL vial (NDC 0641-6247-25) This presentation is temporarily on backorder. Demand increase for the drug

Hospira, Inc. (Revised 09/12/2022)

Company Contact Information:
844-646-4398

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 and Estimated Recovery: February 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) Next Delivery and Estimated Recovery: December 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
250 mcg/5 mL (50 mcg/mL); Glass Ampul (NDC 00409-9093-35) Limited Supply Available. Next Delivery: January 2023; Estimated Recovery: May 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
1000 mcg/20 mL (50 mcg/mL); Glass Ampul (NDC 00409-9093-38) Discontinued

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Discontinuation of the manufacture of the drug
100 mcg/2 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-22) Limited Supply Available. Next Delivery and Estimated Recovery: September 2022 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) Next Delivery: September 2022; 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) Limited Supply Available. Next Delivery: December 2022; Estimated Recovery: March 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

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: October 2022; Estimated Recovery: January 2023 Check Wholesaler for Availability 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) Limited Supply Available. Next Delivery: September 2022; Estimated Recovery: January 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
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