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 (New 12/06/2018)

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. Estimated recovery: late December 2018 Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 11/28/2018)

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 December 2018. Check wholesalers for inventory Demand increase for the drug
4 mg per 1 mL, Single dose vial, (NDC 63323-454-01) Backordered. Next release December 2018. Check wholesalers for inventory Demand increase for the drug
5 mg per 1 mL, Single dose vial, (NDC 63323-455-01) Backordered. Next release December 2018. Demand increase for the drug
8 mg per 1 mL, Single dose vial, (NDC 63323-458-01) Backordered. Next release date not available at this time. Demand increase for the drug
10 mg per 1 mL, Single dose vial, (NDC 63323-451-01) Backordered. Next release December 2018. Check wholesalers for inventory Demand increase for the drug
2 mg per 1 mL, Single-use prefilled syringe (NDC 76045-004-10) Backordered. Ongoing intermittent releases - next release January 2019. 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) Backordered. Next release date not available at this time. Check wholesalers for inventory Demand increase for the drug
5 mg per 1 mL, Single-use prefilled syringe (NDC 76045-006-10) Backordered. Next release date not available at this time. 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

Hospira, Inc. (Revised 12/06/2018)

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) Available Other
2 mg/mL (2 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1890-01) Next Delivery: December 2019; Estimated Recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Health Care Provider Letter

Other
2 mg/mL (2 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1890-11) Next Delivery: December 2019; Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
4 mg/mL (4 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1891-01) Next Delivery: February 2019; Estimated Recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
4 mg/mL (4 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1891-11) Next Delivery: December 2019; Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

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

Dear Customer Letter

Other
8 mg/mL (8 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1892-11) Next Delivery: December 2019; Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
10 mg/mL (10 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1893-01) Next Delivery and Estimated Recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
10 mg/mL (10 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1893-11) Next Delivery: December 2019; Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
5 mg/10 mL (0.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3814-12) Available 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: March 2019 Shortage per Manufacturer: Manufacturing Delay Other
1,000 mg/20 mL (50 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1134-03) Limited Supply Available. Next Delivery and Estimated Recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

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

Dear Customer Letter

Other

West-Ward Pharmaceuticals (Revised 10/03/2018)

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) This presentation is temporarily on backorder. Additional lots are scheduled to be manufactured in the November 2018 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 September-October 2018 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 September-October 2018 timeframe. Product will be made available as it is released. Demand increase for the drug

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