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) (Revised 12/13/2019)

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 will be scheduled for manufacturing Product will be made available as it is released. Demand increase for the drug
2 mg/mL, 20 mL vial (NDC 0641-2341-41) Temporarily on backorder. 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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