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 (Revised 12/02/2019)

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) Unavailable. Estimataed recovery Dec 2019 Expected availability Dec, 2019 Demand increase for the drug
10 mg/mL, 5 mL ampule, 10 count (NDC 17478-0540-05) Available Demand increase for the drug
10 mg/mL, 50 mL vial, 10 count (NDC 17478-0540-50) Available Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 12/09/2019)

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) Check wholesalers for inventory Check wholesalers for inventory Demand increase for the drug
(Dilaudid) 1 mg per 1 mL, prefilled syringe (NDC 76045-009-10) Blister pack Check wholesalers for inventory Check wholesalers for inventory Demand increase for the drug
(Dilaudid) 2 mg per 1 mL, prefilled syringe (NDC 76045-010-10) Backordered. Next release date not available at this time. 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. Demand increase for the drug
1 mg per 1 mL, Single dose vial, (NDC 63323-852-25) Available Check wholesalers for inventory Demand increase for the drug
2 mg per 1 mL, Single dose vial, (NDC 63323-853-25) Available Check wholesalers for inventory Demand increase for the drug
4 mg per 1 mL, Single dose vial, (NDC 63323-854-10) Available Check wholesalers for inventory Demand increase for the drug
10 mg per 1 mL, Single dose vial, high potency formulation (HPF), (NDC 63323-851-10) Backordered. Next release not available at this time. Check wholesalers for inventory Demand increase for the drug
50 mg per 5 mL, Single dose vial, high potency formulation (HPF), (NDC 63323-851-15) Available Check wholesalers for inventory Demand increase for the drug
500 mg per 50 mL, Single dose vial, high potency formulation (HPF), (NDC 63323-851-50) Available Check wholesalers for inventory Demand increase for the drug
(Dilaudid) 0.5 mg per 0.5 mL, prefilled syringe (NDC 76045-009-06) Microvault Available Check wholesalers for inventory
(Dilaudid) 1 mg per 1 mL, prefilled syringe (NDC 76045-009-11) Microvault Available Check wholesalers for inventory

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Reverified 10/04/2019)

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) Inventory is currently available. Additional lots are scheduled for manufacturing in the February – March 2019 timeframe. Product will be made available as it is released. Demand increase for the drug
2 mg/mL, 20 mL vial (NDC 0641-2341-41) 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 12/06/2019)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg/0.5 mL (1 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1283-05) Available Other
1 mg/1 mL (1 mg/1 mL); iSecure Luer Lock Glass Syringe (NDC 00409-1283-10) Next Delivery: January 2020; Estimated Recovery: June 2021 Shortage per Manufacturer: Manufacturing Delay Other
2 mg/1 mL (2 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1312-10) Next Delivery: January 2020; Estimated Recovery: June 2021 Shortage per Manufacturer: Manufacturing Delay Other
1 mg/1 mL (1 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1283-31) Available Other
2 mg/1 mL (2 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1312-30) Available Other
4 mg/1 mL (4 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1304-31) Next Delivery and Estimated Recovery: January 2020 Shortage per Manufacturer: Manufacturing Delay Other
1 mg/1 mL (1 mg/mL); Glass Ampul (NDC 00409-2552-01) Limited Supply Available. Next Delivery: December 2019; Estimated Recovery: January 2020 Shortage per Manufacturer: Manufacturing Delay Other
2 mg/1 mL (2 mg/mL); Glass Ampul (NDC 00409-3356-01) Next Delivery: April 2020; Estimated Recovery: August 2020 Shortage per Manufacturer: Manufacturing Delay Other
4 mg/1 mL (4 mg/mL); Glass Ampul (NDC 00409-2540-01) Next Delivery: December 2019; Estimated Recovery: August 2020 Shortage per Manufacturer: Manufacturing Delay Other
2 mg/1 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3365-01) Available Other
10 mg/mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2634-01) Next Delivery: December 2019; Estimated Recovery: August 2020 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
50 mg/5 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2634-05) Available Other
500 mg/50 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2634-50) Available Other

Teva Pharmaceuticals (Reverified 12/04/2019)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 MG/1ML (NDC0703-0110-03) Available Other
10 MG/1ML (NDC 0703-0113-03) Available Other
10 MG/1 ML (NDC 0703-0018-01) Available Other

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