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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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 Trace Elements

 Status: Currently in Shortage

 » Date first posted: 01/24/2013
 » Therapeutic Categories: Gastroenterology; Pediatric; Total Parenteral Nutrition

American Regent/Luitpold (Revised 05/18/2015)

Company Contact Information:
800-645-1706

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Multitrace-4 Neonatal, 2 mL vial (NDC 00517-6202-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.
Multitrace-4 Regular, 10 mL vial (NDC 00517-7410-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.
Multitrace-4 Pediatric, 3 mL vial (NDC 00517-9203-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.
Multitrace-5 Regular, 10 mL vial (NDC 00517-8510-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.
Multitrace-5 Concentrate 10 mL vial (NDC 00517-8210-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.
Multitrace-4 Concentrate, 1 mL vial (NDC 00517-7201-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.
Multitrace-4 Concentrate, 10 mL vial (NDC 00517-7210-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.
Multitrace-5 Concentrate 1 mL vial (NDC 00517-8201-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.
Trace elements-4 pediatric injection, 10 mL vial (NDC 00517-9310-25) Available for NDCs 00517-6202-25, 00517-7201-25, 00517-7210-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply), 00517-8210-25 (limited supply), 00517-8510-25, 00517-9203-25 and 00517-9310-25 (limited supply). American Regent is currently releasing MTE-4 Neonatal 2 mL vial (NDC 00517-6202-25), MTE-4 Conc. 1 mL vial (NDC 00517-7201-25), MTE-4 Conc, 10 mL vial (NDC 00517-7210-25), MTE-4 Regular, 10 mL vial (NDC 00517-7410-25), MTE-5 Conc. 1 mL vial (NDC 00517-8201-25), MTE-5 Conc. 10 mL vial (NDC 00517-8210-25), MTE-5 10 mL vial (NDC 00517-8510-25), MTE-4 ped. 3 mL vial (NDC 00517-9203-25); and Trace Elements-4 ped. 10 mL vial (NDC 00517-9310-25). Delay in shipping of the drug and demand increase for the drug.

Fresenius Kabi USA, LLC (Reverified 05/19/2015)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Addamel N injection, 10 mL ampule (NDC 63323-143-97) Importation began May 2013 and will continue until all patient needs are met with US product. Ample available direct and through wholesalers. Clinicians can order the product at pre-shortage levels. Please check wholesalers for inventory and reference Addamel N. Available. Please check wholesalers for inventory. Fresenius Kabi USA, LLC (FK USA) in conjunction with FDA has initiated temporary importation of Addamel N (adult trace elements) injection into the US market to address this shortage. Please see the Dear Healthcare Professional Letter for additional product and supply information. FK USA is releasing Addamel N to its authorized distributors. Shortage per Manufacturer: Increase in demand

Dear Healthcare Professional Letter

Demand increase for the drug
Peditrace injection, 10 mL vial (NDC 63323-147-10) Importation began May 2013 and will continue until all patient needs are met with US product. Ample product available direct and through wholesalers. Clinicians can order the product at pre-shortage levels. Please check wholesalers for inventory. Fresenius Kabi USA, LLC (FK USA) in conjunction with FDA has initiated temporary importation of Addamel N (adult trace elements) injection into the US market to address this shortage. Please see the Dear Healthcare Professional Letter for additional product and supply information. FK USA is releasing Addamel N to its authorized distributors. Shortage per Manufacturer: Increase in demand

Dear Healthcare Professional Letter

Demand increase for the drug
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