FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Hydromorphone Hydrochloride Injection, USP
Status: Currently in Shortage
»Date first posted: 10/31/2017
»Therapeutic Categories: Analgesia/Addiction

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Akorn Pharmaceuticals (New 10/31/2017)

Company Contact Information:
800-932-5676

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mg/mL, 1 mL ampule, 10 count (NDC 17478-0540-01) Available Other
10 mg/mL, 5 mL ampule, 10 count (NDC 17478-0540-05) Available Other
10 mg/mL, 50 mL vial, 10 count (NDC 17478-0540-50) Available Other

Fresenius Kabi USA, LLC (Revised 11/17/2017)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
(Dilaudid) 0.5 mg per 0.5 mL, prefilled syringe (NDC 76045-009-05) Backordered. Next release anticipated December 2017. Check Wholesalers for Inventory Demand increase for the drug
(Dilaudid) 1 mg per 1 mL, prefilled syringe (NDC 76045-009-10) Backordered. Next release anticipated December 2017. Check Wholesalers for Inventory Demand increase for the drug
(Dilaudid) 2 mg per 1 mL, prefilled syringe (NDC 76045-010-10) Backordered. Next release anticipated Q1 -2018. Check Wholesalers for Inventory Demand increase for the drug
(Dilaudid) 4 mg per 1 mL, prefilled syringe (NDC 76045-011-10) Backordered. Next release date not available at this time. Check Wholesalers for Inventory Demand increase for the drug

Hospira, Inc. (Revised 11/13/2017)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg/0.5 mL iSecure™ Luer Lock Glass Syringe (no needle) (NDC 0409-1283-05) Next delivery: Early December 2017. Estimated recovery: June 2018 Shortage per Manufacturer: Manufacturing Delay Other
1 mg/mL iSecure™ Luer Lock Glass Syringe (no needle) (NDC 0409-1283-10) Next delivery: Mid November 2017. Estimated recovery: September 2018 Shortage per Manufacturer: Manufacturing Delay Other
2 mg/mL iSecure™ Luer Lock Glass Syringe (no needle) (NDC 0409-1312-10) Next delivery: 3Q 2018. Estimated recovery: September 2018 Shortage per Manufacturer: Manufacturing Delay Other
1 mg/mL Carpuject™ Luer Lock Glass Syringe (no needle) (NDC 0409-1283-31) Next delivery: Mid November 2017. Estimated recovery: June 2018 Shortage per Manufacturer: Manufacturing Delay Other
2 mg/mL Carpuject™ Luer Lock Glass Syringe (no needle) (NDC 0409-1312-30) Next delivery: Late January 2018. Estimated recovery: June 2018 Shortage per Manufacturer: Manufacturing Delay Other
4 mg/mL Carpuject™ Luer Lock Glass Syringe (no needle) (NDC 0409-1304-31) Next delivery: 3Q 2018. Estimated recovery: September 2018 Shortage per Manufacturer: Manufacturing Delay Other
1 mg/mL Glass Ampul (NDC 0409-2552-01) Next delivery: Early December 2017. Estimated recovery: June 2018 Shortage per Manufacturer: Manufacturing Delay Other
2 mg/mL Glass Ampul (NDC 0409-3356-01) Next delivery: 1Q 2018. Estimated recovery: March 2018 Shortage per Manufacturer: Manufacturing Delay Other
4 mg/mL Glass Ampul (NDC 0409-2540-01) Available Available Other
2 mg/mL Single Dose Glass Fliptop Vial (NDC 0409-3365-01) Next delivery: Early December 2017. Estimated recovery: March 2018 Shortage per Manufacturer: Manufacturing Delay Other
10 mg/mL (10 mg/mL) Single Dose Glass Fliptop Vial (NDC 0409-2634-01) Next delivery: Mid December 2017. Estimated recovery: June 2018 Shortage per Manufacturer: Manufacturing Delay Other
10 mg/mL (50 mg/5 mL) Single Dose Glass Fliptop Vial (NDC 0409-2634-05) Next delivery: Mid December 2017. Estimated recovery: December 2018 Shortage per Manufacturer: Manufacturing Delay Other
10 mg/mL (500 mg/50 mL) Single Dose Glass Fliptop Vial (NDC 0409-2634-50) Available Available Other

Teva Pharmaceuticals (New 11/01/2017)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 MG/1ML (NDC0703-0110-03) Next release for late December 2017 Manufacturing delay Other
10 MG/1ML (NDC 0703-0113-03) Next release for late December 2017 Manufacturing delay Other
10 MG/1 ML (NDC 0703-0018-01) Next release for late December 2017 Manufacturing delay Other

West-Ward Pharmaceuticals (New 11/03/2017)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg/mL, 1 mL vial (NDC 0641-0121-25) This presentation is temporarily on backorder. Product will be made available as it is released- estimated release 1Q 2018 Demand increase for the drug
2 mg/mL, 20 mL vial (NDC 0641-2341-41) This presentation is temporarily on backorder. Product will be made available as it is released- estimated release 1Q 2018 Demand increase for the drug

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