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U.S. Department of Health and Human Services

FDA Drug Shortages

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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 reported: 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

Bedford Laboratories (Revised 07/09/2014)

Company Contact Information:
800-562-4797

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg (NDC 55390-0005-10) Unavailable Shortage: Pending Manufacturing Change or Addition. Availability of products are updated on the Bedford Laboratories website. Other
100 mg (NDC 55390-0052-10) Unavailable Shortage: Pending Manufacturing Change or Addition. Availability of products are updated on the Bedford Laboratories website. Other
200 mg (NDC 55390-0053-01) Unavailable Shortage: Pending Manufacturing Change or Addition. Availability of products are updated on the Bedford Laboratories website. Other
350mg (NDC 55390-0054-01) Unavailable Check wholesaler for inventory Other
500mg 50mL solution (NDC 55390-0009-01) Unavailable Shortage: Pending Manufacturing Change or Addition. Availability of products are updated on the Bedford Laboratories website. Other

Fresenius Kabi USA, LLC (Revised 11/24/2014)

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 wholesalers for inventory Demand increase for the drug
500 mg SDV (NDC 63323-711-00) Backordered. Next release anticipated December 2014. Check wholesalers for inventory Manufacturing delay

Sagent Pharmaceuticals (Reverified 11/10/2014)

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) Available Other
100mg vial (NDC 25021-814-30) Available Other
200mg vial (NDC 25021-815-30) Available Other
350mg vial (NDC 25021-816-30) Available Other

Teva Pharmaceuticals (Revised 11/13/2014)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
100mg/vial (NDC 0703-5140-01) 20mL Teva 00703-5145-01 Lyopholized Leucovorin is currently in inventory. 100mg product expected to become available end Q414. See Dear Healthcare Professional letter for additional information. Teva only has the 30ml presentation of Calcium Folinate Solution available, NDC 00703-2797-01.

Dear Healthcare Professional letter

Regulatory delay
350mg/vial 30mL (NDC 00703-5145-01) Teva 00703-5145-01 Lyopholized Leucovorin is currently in inventory. 100mg product expected to become available end Q414. See Dear Healthcare Professional letter for additional information. Teva only has the 30ml presentation of Calcium Folinate Solution available, NDC 00703-2797-01.

Dear Healthcare Professional letter

Regulatory delay
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