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

Hospira, Inc. (Revised 12/06/2018)

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: December 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
100 mcg/2 mL (50 mcg/mL); Glass Ampul (NDC 00409-9093-32) Next Delivery: December 2018; 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: December 2018; Estimated Recovery: January 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: December 2018; Estimated Recovery: March 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) Limited Supply Available. Next Delivery: December 2018; Estimated Recovery: March 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other

West-Ward Pharmaceuticals (Reverified 10/03/2018)

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 in the September - October 2018 timeframe. Demand increase for the drug
50 mcg/mL 5 mL ampul (NDC 0641-6025-10) Inventory is currently available. Additional lots will be scheduled for manufacturing. Product will be made available in the September - October 2018 timeframe. Demand increase for the drug
50 mcg/mL 20 mL ampul (NDC 0641-6026-05) Inventory is currently available. Additional lots will be scheduled for manufacturing. Product will be made available in the September - October 2018 timeframe. 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. Product will be made available in the August - September 2018 timeframe. 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. Product will be made available in the September - October 2018 timeframe. Regulatory delay
50 mcg/mL 20 mL vial (NDC 0641-6029-25) Inventory is currently available. Additional lots will be scheduled for manufacturing. Product will be made available in the September 2018 timeframe. 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. Product will be made available in the August - September 2018 timeframe. Demand increase for the drug

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