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
Amphastar Pharmaceuticals, Inc./IMS (New 12/06/2018)
| 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 02/06/2019)
| 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 March 2019. | Check wholesalers for inventory | Demand increase for the drug |
| 4 mg per 1 mL, Single dose vial, (NDC 63323-454-01) | Backordered. Next release March 2019. | 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) | 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) | Available | 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 February 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 Q2 - 2019. | 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 Q2 - 2019. | 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 02/05/2019)
| 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 April 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 April 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 April 2019 timeframe. Product will be made available as it is released. | Demand increase for the drug |
Hospira, Inc. (Revised 02/15/2019)
| 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 and Estimated Recovery: June 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 2 mg/mL (2 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1890-01) | Limited Supply Available. Next Delivery: February 2019; Estimated Recovery: June 2019 | Shortage per Manufacturer: Manufacturing Delay | 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 | Other |
| 4 mg/mL (4 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1891-01) | Next Delivery: June 2019; Estimated Recovery: September 2019 | Shortage per Manufacturer: Manufacturing Delay | 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 | 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 | 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 | 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 | 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 | Other |
| 5 mg/10 mL (0.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3814-12) | Limited Supply Available. Next Delivery and Estimated Recovery: March 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 10 mg/10 mL (1 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3815-12) | Next Delivery: March 2019; Estimated Recovery: June 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 | Other |
| 2,500 mg/50 mL (50 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1134-05) | Next Delivery and Estimated Recovery: June 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
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