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 12/02/2019)

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) Available Other
5 mL ampule 10 pack (NDC 17478-0030-05) Available Other
20 mL ampule (NDC 17478-0030-20) Available Other
5 mL ampule 25 pack (NDC 17478-0030-55) Available Other

Fresenius Kabi USA, LLC (Reverified 03/24/2020)

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 April 2020. 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 April 2020. 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

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 02/07/2020)

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 Inventory available in vial presentations. Demand increase for the drug
50 mcg/mL 5 mL ampul (NDC 0641-6025-10) Currently not available 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) Inventory is currently available. Additional lots will be scheduled for manufacturing as needed. Product will be made available as it is released. Demand increase for the drug
50 mcg/mL 5 mL vial (NDC 0641-6028-25) Inventory is currently available. Additional lots will be scheduled for manufacturing as needed. Product will be made available as it is released. Demand increase for the drug
50 mcg/mL 20 mL vial (NDC 0641-6029-25) Inventory is currently available. Additional lots will be scheduled for manufacturing as needed. Product will be made available as it is released. Demand increase for the drug
50 mcg/mL 50 mL vial (NDC 0641-6030-01) Inventory is currently available. Additional lots will be scheduled for manufacturing as needed. Product will be made available as it is released. Demand increase for the drug

Hospira, Inc. (Revised 03/25/2020)

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: January 2023 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) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
250 mcg/5 mL (50 mcg/mL); Glass Ampul (NDC 00409-9093-35) Available

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: March 2020; Estimated Recovery: January 2021 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) Available

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) Next Delivery: March 2020; Estimated Recovery: April 2020 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: April 2020; Estimated Recovery: February 2021 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other

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