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 12/09/2019)

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	Check wholesalers for 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 12/06/2019)

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)	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)	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)	Available	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 and 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: December 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 11/27/2019)

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