FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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

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Akorn Pharmaceuticals (Reverified 05/19/2021)

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
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 05/04/2022)

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) Backordered. Next release June 2022. Check wholesalers for inventory Demand increase for the drug
2 mg per 1 mL, Single dose vial, (NDC 63323-853-25) Backordered. Next release May 2022. 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) Available 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) Backordered. Next release May 2022. 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
(Dilaudid) 0.2 mg per 1 mL, prefilled syringe, MicroVault packaging (NDC 76045-121-11) Available Check wholesalers for inventory
(Dilaudid) 2 mg per 1 mL, prefilled syringe, MicroVault packaging (NDC 76045-010-11) Available Check wholesalers for inventory

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 04/08/2022)

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. Additional lots are scheduled for manufacturing and will be available in the May 2022 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) This presentation is temporarily on backorder. Additional lots are scheduled for manufacturing and will be available in the May 2022 timeframe. Product will be made available as it is released. Demand increase for the drug

Hospira, Inc. (Revised 05/10/2022)

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) Limited Supply Available. Next Delivery: May 2022; Estimated Recovery: July 2022 Shortage per Manufacturer: Manufacturing Delay Other
1 mg/1 mL (1 mg/1 mL); iSecure Luer Lock Glass Syringe (NDC 00409-1283-10) Discontinued Discontinuation of the manufacture of the drug
2 mg/1 mL (2 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1312-10) Discontinued Discontinuation of the manufacture of the drug
1 mg/1 mL (1 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1283-31) Limited Supply Available. Next Delivery and Estimated Recovery: May 2022 Demand increase for the drug
2 mg/1 mL (2 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1312-30) Limited Supply Available. Next Delivery and Estimated Recovery: June 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
4 mg/1 mL (4 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1304-31) Available Other
1 mg/1 mL (1 mg/mL); Glass Ampul (NDC 00409-2552-01) Next Delivery and Estimated Recovery: September 2022 Demand increase for the drug
2 mg/1 mL (2 mg/mL); Glass Ampul (NDC 00409-3356-01) Discontinued Discontinuation of the manufacture of the drug
4 mg/1 mL (4 mg/mL); Glass Ampul (NDC 00409-2540-01) Discontinued Discontinuation of the manufacture of the drug
2 mg/1 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3365-01) Discontinued Discontinuation of the manufacture of the drug
10 mg/mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2634-01) Limited Supply Available. Next Delivery and Estimated Recovery: May 2022 Demand increase for the drug
50 mg/5 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2634-05) Next Delivery and Estimated Recovery: May 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
500 mg/50 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2634-50) Limited Supply Available. Next Delivery: August 2022; Estimated Recovery: January 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other

Teva Pharmaceuticals (Revised 05/19/2022)

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
10 MG/1ML (NDC 0703-0113-03) Product is on Backorder - Resupply due early June
10 MG/1 ML (NDC 0703-0018-01) Available

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