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 11/21/2016)

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

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Reverified 04/05/2019)

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) This presentation is temporarily on backorder. Additional lots will be scheduled for manufacturing. Product will be made available as it is released. Demand increase for the drug
50 mcg/mL 5 mL ampul (NDC 0641-6025-10) This presentation is temporarily on backorder. Additional lots will be scheduled for manufacturing. Product will be made available as it is released. Demand increase for the drug
50 mcg/mL 20 mL ampul (NDC 0641-6026-05) This presentation is temporarily on backorder. Additional lots will be scheduled for manufacturing. Product will be made available as it is released. 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. Regulatory delay
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 04/09/2019)

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: September 2019; Estimated Recovery: October 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
100 mcg/2 mL (50 mcg/mL); Glass Ampul (NDC 00409-9093-32) Limited Supply Available. Next Delivery: April 2019; Estimated Recovery: June 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

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

Dear Customer Letter

Other
1000 mcg/20 mL (50 mcg/mL); Glass Ampul (NDC 00409-9093-38) Discontinued 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: April 2019; Estimated Recovery: June 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
250 mcg/5 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-25) Available

Dear Customer Letter

Other
500 mcg/10 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-28) Available

Dear Customer Letter

Other
1,000 mcg/20 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-31) Limited Supply Available. Next Delivery: June 2019; Estimated Recovery: July 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
2,500 mcg/50 mL (50 mcg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9094-61) Available

Dear Customer Letter

Other

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