FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Leucovorin Calcium Lyophilized Powder for Injection
Status: Currently in Shortage
»Date first posted: No date available
»Therapeutic Categories: Oncology; Pediatric

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Fresenius Kabi USA, LLC (Revised 09/23/2021)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
200 mg SDV (NDC 63323-710-50) Backordered. Next release October 2021. Check Wholesaler Inventory Demand increase for the drug
500 mg SDV (NDC 63323-711-00) Backordered. Next release October 2021. Check Wholesaler Inventory Manufacturing delay
100 mg per 10 mL (10 mg per mL) Single dose amber vial, liquid (NDC 63323-631-10) Backordered. Next release January 2022. Check Wholesaler Inventory Manufacturing Delay
500 mg per 50 mL (10 mg per mL) Single dose amber vial, liquid (NDC 63323-631-50) Backordered. Next release January 2022. Check Wholesaler Inventory Manufacturing Delay

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Reverified 07/06/2021)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg, 10 mL vial (NDC 0143-9555-01) Inventory is currently available. Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. Demand increase for the drug
100 mg, 20 mL vial (NDC 0143-9554-01) Inventory is currently available. Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. Demand increase for the drug
200 mg, 30 mL vial (NDC 0143-9553-01) Inventory is currently available. Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. Demand increase for the drug
350 mg, 50 mL vial (NDC 0143-9552-01) Inventory is currently available. Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. Demand increase for the drug

Mylan Institutional, a Viatris company (Reverified 09/16/2021)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
100 mg vial (NDC 67457-528-10) Intermittent Supply Demand increase for the drug
200 mg vial (NDC 67457-529-20) Available Demand increase for the drug
350 mg vial (NDC 67457-530-35) Intermittent Supply Demand increase for the drug

Sagent Pharmaceuticals (Reverified 09/03/2021)

Company Contact Information:
866-625-1618

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg vial (NDC 25021-813-10) Backordered. Estimated availability July-2021 Manufacturing delay
100mg vial (NDC 25021-814-30) Available Manufacturing delay
200mg vial (NDC 25021-815-30) Available.
350mg vial (NDC 25021-816-30) Available.
500mg vial (NDC 25021-828-50) Available Manufacturing delay

Teva Pharmaceuticals (Reverified 09/20/2021)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
100mg/vial, 20mL (NDC 0703-5140-01) Backordered – Estimated date of availability TBD Demand increase for the drug
350mg/vial 30mL (NDC 0703-5145-01) Backordered – Estimated date of availability TBD Demand increase for the drug

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