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 (Reverified 10/18/2019)

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)	Backordered. Next release November 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 10/09/2019)

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

Hospira, Inc. (Revised 10/07/2019)

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)	Next Delivery: October 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: October 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. (New 10/02/2019)

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