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

Please note Levoleucovorin (Fusilev) is available in ample quantities. There is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev). The dose of levoleucovorin (Fusilev) is one-half the dose of racemic leucovorin injection (e.g., levoleucovorin [Fusilev] 7.5 mg = racemic leucovorin 15 mg). For more information visit the Spectrum Pharmaceuticals web site.
Spectrum Pharmaceuticals

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Fresenius Kabi USA, LLC (Reverified 07/15/2016)

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) Available Check Wholesaler Inventory Demand increase for the drug
500 mg SDV (NDC 63323-711-00) Backordered. Next release anticipated July 2016. Manufacturing delay

Sagent Pharmaceuticals (Reverified 05/16/2016)

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 Demand increase for the drug
100mg vial (NDC 25021-814-30) Available Demand increase for the drug
200mg vial (NDC 25021-815-30) Available Demand increase for the drug
350mg vial (NDC 25021-816-30) Available Demand increase for the drug

Teva Pharmaceuticals (Reverified 06/30/2016)

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) Product is currently available.

Dear Healthcare Professional letter

Regulatory delay
350mg/vial 30mL (NDC 00703-5145-01) Product is currently available.

Dear Healthcare Professional letter

Regulatory delay

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