FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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

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Amphastar Pharmaceuticals, Inc./IMS (Revised 01/24/2022)

Company Contact Information:
800-423-4136

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
30 mg/30 mL (1 mg/1 mL) Single-Dose (Preservative-Free PCA Vial), (NDC 76329-1912-1) Available

Fresenius Kabi USA, LLC (Revised 01/18/2022)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg per 1 mL, Single dose vial, (NDC 63323-452-01) Backordered. Next release February 2022. Check wholesalers for inventory
4 mg per 1 mL, Single dose vial, (NDC 63323-454-01) Backordered. Next release February 2022. Check wholesalers for inventory Demand increase for the drug
5 mg per 1 mL, Single dose vial, (NDC 63323-455-01) Available Check wholesalers for inventory
8 mg per 1 mL, Single dose vial, (NDC 63323-458-01) Backordered. Next release not available at this time. Demand increase for the drug
10 mg per 1 mL, Single dose vial, (NDC 63323-451-01) Available Check wholesalers for inventory
2 mg per 1 mL, Single-use prefilled syringe, micro vault packaging (NDC 76045-004-11) Backordered. Next release February 2022. Check wholesalers for inventory
4 mg per 1 mL, Single-use prefilled syringe, micro vault packaging (NDC 76045-005-11) Backordered. Next release February 2022. Check wholesalers for inventory
2 mg per 1 mL, Single-use prefilled syringe (NDC 76045-004-10) Check wholesalers for inventory Check wholesalers for inventory
4 mg per 1 mL, Single-use prefilled syringe (NDC 76045-005-10) Check wholesalers for inventory Check wholesalers for inventory
5 mg per 1 mL, Single-use prefilled syringe (NDC 76045-006-10) Available Check wholesalers for inventory
8 mg per 1 mL, Single-use prefilled syringe (NDC 76045-007-10) Backordered. Next release date not available at this time. Demand increase for the drug
10 mg per 1 mL, Single-use prefilled syringe (NDC 76045-008-10) Backordered. Next release not available at this time. Demand increase for the drug

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 01/13/2022)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg/mL, 1 mL vial (NDC 0641-6125-25) Inventory is currently available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Demand increase for the drug
8 mg/mL, 1 mL vial (NDC 0641-6126-25) Inventory is currently available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Demand increase for the drug
10 mg/mL, 1 mL vial (NDC 0641-6127-25) This presentation is temporarily on backorder. Additional lots are scheduled for manufacturing and will be available in the January 2022 timeframe. Product will be made available as it is released. Demand increase for the drug
Duramorph (Preservative-Free) 1 mg/mL, 10 mL ampul (NDC 0641-6019-10) This presentation is temporarily on backorder. Additional lots will be scheduled for manufacturing in the October - November 2021 timeframe. Product will be made available as it is released. Demand increase for the drug
Duramorph (Preservative-Free) 0.5 mg/mL, 10 mL ampul (NDC 0641-6020-10) This presentation is temporarily on backorder. Additional lots will be scheduled for manufacturing in the October - November 2021 timeframe. Product will be made available as it is released. Demand increase for the drug
Infumorph (Preservative-free Morphine Sulfate Sterile Solution) 10 mg/mL, 20 mL ampul (NDC 0641-6039-01) Inventory is currently available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Demand increase for the drug
Infumorph (Preservative-free Morphine Sulfate Sterile Solution) 25 mg/mL, 20 mL ampul (NDC 0641-6040-01) Inventory is currently available. Additional lots are scheduled to be manufactured. Product will be made available as it is released. Demand increase for the drug

Hospira, Inc. (Revised 01/21/2022)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250 mg/10 mL (25 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1135-02) Discontinued

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Discontinuation of the manufacture of the drug
2 mg/mL (2 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1890-01) Limited Supply Available. Next Delivery: February 2022; Estimated Recovery: May 2022 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
2 mg/mL (2 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1890-11) Discontinued Discontinuation of the manufacture of the drug
4 mg/mL (4 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1891-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
4 mg/mL (4 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1891-11) Discontinued Discontinuation of the manufacture of the drug
8 mg/mL (8 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1892-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
8 mg/mL (8 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1892-11) Discontinued Discontinuation of the manufacture of the drug
10 mg/mL (10 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1893-01) Limited Supply Available. Next Delivery and Estimated Recovery: January 2022

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
10 mg/mL (10 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1893-11) Discontinued Discontinuation of the manufacture of the drug
5 mg/10 mL (0.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3814-12) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
10 mg/10 mL (1 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3815-12) Limited Supply Available. Next Delivery and Estimated Recovery: January 2022

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
1,000 mg/20 mL (50 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1134-03) Next Delivery and Estimated Recovery: March 2022

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
2,500 mg/50 mL (50 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1134-05) Next Delivery and Estimated Recovery: February 2022

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug

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