FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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

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Amphastar Pharmaceuticals, Inc./IMS (Revised 10/23/2019)

Company Contact Information:
800-423-4136

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Morphine Sulfate 1 mg/mL 30 mg in 30 mL PUMP-JET® SUITABLE FOR USE WITH COMPATIBLE I.V. INFUSION PUMPS Product is being regularly released.

Fresenius Kabi USA, LLC (Revised 11/12/2019)

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) Available Check wholesalers for inventory Demand increase for the drug
4 mg per 1 mL, Single dose vial, (NDC 63323-454-01) Available 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 Demand increase for the drug
8 mg per 1 mL, Single dose vial, (NDC 63323-458-01) Available Demand increase for the drug
10 mg per 1 mL, Single dose vial, (NDC 63323-451-01) Available Check wholesalers for inventory Demand increase for the drug
2 mg per 1 mL, Single-use prefilled syringe (NDC 76045-004-10) Available All Morphine presentations are on intermittent back order and will be released to the wholesaler channel as the product becomes available. Check wholesaler inventory. Demand increase for the drug
4 mg per 1 mL, Single-use prefilled syringe (NDC 76045-005-10) Available Check wholesalers for inventory Demand increase for the drug
5 mg per 1 mL, Single-use prefilled syringe (NDC 76045-006-10) Available Check wholesalers for inventory Demand increase for the drug
8 mg per 1 mL, Single-use prefilled syring (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 date not available at this time. Demand increase for the drug

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 10/31/2019)

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 in the November - December 2019 timeframe. 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 in the November - December 2019 timeframe. Product will be made available as it is released. Demand increase for the drug
10 mg/mL, 1 mL vial (NDC 0641-6127-25) Inventory is currently available. Additional lots are scheduled to be manufactured in the November - December 2019 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) 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
Duramorph (Preservative-Free) 0.5 mg/mL, 10 mL ampul (NDC 0641-6020-10) 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
Infumorph (Preservative-free Morphine Sulfate Sterile Solution) 10 mg/mL, 20 mL ampul (NDC 0641-6039-01) 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
Infumorph (Preservative-free Morphine Sulfate Sterile Solution) 25 mg/mL, 20 mL ampul (NDC 0641-6040-01) 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 11/08/2019)

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) Next Delivery: March 2020; Estimated Recovery: April 2020 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
2 mg/mL (2 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1890-01) Available

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) Next Delivery and Estimated Recovery: August 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
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) Next Delivery and Estimated Recovery: August 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
8 mg/mL (8 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1892-01) Next Delivery: December 2019; Estimated Recovery: April 2020 Shortage per Manufacturer: Manufacturing Delay

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) Next Delivery and Estimated Recovery: August 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
10 mg/mL (10 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1893-01) Next Delivery: December 2019; Estimated Recovery: April 2020 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
10 mg/mL (10 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1893-11) Next Delivery and Estimated Recovery: August 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
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: November 2019; Estimated Recovery: December 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
1,000 mg/20 mL (50 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1134-03) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
2,500 mg/50 mL (50 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1134-05) Next Delivery: November 2019; Estimated Recovery: March 2020 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other

ICU Medical, Inc. (Reverified 11/15/2019)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1mg/mL 30mL PCA glass vial (NDC 0409-2029-02) Unavailable ICU Medical acquired these products from Hospira, a Pfizer company. For questions or inquiries regarding these Hospira labeled products, please contact ICU Medical. Other

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