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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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Fresenius Kabi USA, LLC (Revised 06/05/2024)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, 1 mg/1 mL (NDC 63323-852-25) Available Check wholesalers for inventory
Injection, 2 mg/1 mL (NDC 63323-853-25) Unavailable Backordered. Next release not available at this time. Demand increase for the drug
Injection, 4 mg/1 mL (NDC 63323-854-10) Available Check wholesalers for inventory
Injection, 10 mg/1 mL (NDC 63323-851-10) Unavailable Backordered. Next release not available at this time; Check wholesalers for inventory Delay in shipping of the drug
Injection, 10 mg/1 mL (NDC 63323-851-15) Unavailable Backordered. Next release June 2024; Check wholesalers for inventory Delay in shipping of the drug
Injection, 10 mg/1 mL (NDC 63323-851-50) Unavailable Backordered. Next release June 2024; Check wholesalers for inventory Demand increase for the drug
Dilaudid, Injection, 1 mg/1 mL (NDC 76045-009-11) Available Check wholesalers for inventory
Dilaudid, Injection, .2 mg/1 mL (NDC 76045-121-11) Available Check wholesalers for inventory
Dilaudid, Injection, 2 mg/1 mL (NDC 76045-010-11) Available Check wholesalers for inventory

Hikma Pharmaceuticals USA, Inc. (Revised 05/23/2024)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Hydromorphone HCl Injection, USP, Injection, 2 mg/1 mL (NDC 0641-0121-25) Available Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released.
Hydromorphone HCl Injection, USP, Injection, 2 mg/1 mL (NDC 0641-2341-41) Available Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released.

Hospira, Inc., a Pfizer Company (Revised 06/13/2024)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Hydromorphone Hydrochloride, Injection, 1 mg/1 mL Syringes (NDC 0409-1283-31) Limited Availability Limited Supply Available. Next Delivery: June 2024; Estimated Recovery: December 2024

Dear Customer Letter (HYPERLINK)

Demand increase for the drug
Hydromorphone Hydrochloride, Injection, 2 mg/1 mL Syringes (NDC 0409-1312-30) Available

Dear Customer Letter (HYPERLINK)

Hydromorphone Hydrochloride, Injection, 4 mg/1 mL Syringes (NDC 0409-1304-31) Limited Availability Limited Supply Available. Next Delivery: August 2024; Estimated Recovery: December 2024; Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter (HYPERLINK)

Demand increase for the drug
Hydromorphone Hydrochloride, Injection, 1 mg/1 mL (NDC 0409-2552-01) Unavailable Next Delivery and Estimated Recovery: June 2025; Shortage per Manufacturer: Manufacturing Delay Demand increase for the drug
Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0409-2634-01) Unavailable Next Delivery: January 2025; Estimated Recovery: March 2025

Dear Customer Letter (HYPERLINK)

Demand increase for the drug
Hydromorphone Hydrochloride, Injection, 50 mg/5 mL (10 mg/mL) (NDC 0409-2634-05) Unavailable Next Delivery: January 2025; Estimated Recovery: March 2025

Dear Customer Letter (HYPERLINK)

Demand increase for the drug
Hydromorphone Hydrochloride, Injection, 500 mg/50 mL (10 mg/mL) (NDC 0409-2634-50) Limited Availability Next Delivery: January 2025; Estimated Recovery: March 2025

Dear Customer Letter (HYPERLINK)

Demand increase for the drug

Teva Pharmaceuticals USA, Inc. (Revised 05/15/2024)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Hydromorphone Hydrochloride Injection, USP CII, Injection, 10 mg/1 mL (NDC 0703-0110-03) Limited Availability Estimated recovery August 2024 Demand increase for the drug
Hydromorphone Hydrochloride Injection, USP CII, Injection, 10 mg/1 mL (NDC 0703-0113-03) Limited Availability Estimated Recovery July 2024 Demand increase for the drug
Hydromorphone Hydrochloride Injection, USP CII, Injection, 10 mg/1 mL (NDC 0703-0018-01) Available
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