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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 (Reverified 12/11/2014)

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 (limited supply), 00517-7201-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply) 00517-9203-25 and 00517-9310-25. 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 regular 10 mL vial (NDC 00517-7410-25); MTE-5 Conc. 1 mL vial (NDC 00517-8201-25); MTE-4 ped. 3 mL vial (NDC 00517-9203-25); 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 (limited supply), 00517-7201-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply) 00517-9203-25 and 00517-9310-25. 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 regular 10 mL vial (NDC 00517-7410-25); MTE-5 Conc. 1 mL vial (NDC 00517-8201-25); MTE-4 ped. 3 mL vial (NDC 00517-9203-25); 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 (limited supply), 00517-7201-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply) 00517-9203-25 and 00517-9310-25. 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 regular 10 mL vial (NDC 00517-7410-25); MTE-5 Conc. 1 mL vial (NDC 00517-8201-25); MTE-4 ped. 3 mL vial (NDC 00517-9203-25); 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) Unavailable for NDCs 00517-7210-25, 00517-8510-25, and 00517-8210-25. Product on backorder and will be made available as it is released. Shortage per Manufacturer: Manufacturing delay Delay in shipping of the drug and demand increase for the drug.
Multitrace-5 Concentrate 10 mL vial (NDC 00517-8210-25) Unavailable for NDCs 00517-7210-25, 00517-8510-25, and 00517-8210-25. Product on backorder and will be made available as it is released. Shortage per Manufacturer: Manufacturing delay 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 (limited supply), 00517-7201-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply) 00517-9203-25 and 00517-9310-25. American Regent is currently releasing MTE-4 neonatal 2 mL vial (code 6202); MTE-4 Conc. 1 mL vial (code 7201); MTE-4 regular 10 mL vial (code 7410); MTE-5 Conc. 1 mL vial (code 8201); Trace Elements-4 ped. 10 mL vial (code 9310). Shortage per Manufacturer: Manufacturing delay Delay in shipping of the drug and demand increase for the drug.
Multitrace-4 Concentrate, 10 mL vial (NDC 00517-7210-25) Unavailable for NDCs 00517-7210-25, 00517-8510-25, and 00517-8210-25. Product on backorder and will be made available as it is released. Shortage per Manufacturer: Manufacturing delay 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 (limited supply), 00517-7201-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply) 00517-9203-25 and 00517-9310-25. 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 regular 10 mL vial (NDC 00517-7410-25); MTE-5 Conc. 1 mL vial (NDC 00517-8201-25); MTE-4 ped. 3 mL vial (NDC 00517-9203-25); 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 (limited supply), 00517-7201-25 (limited supply), 00517-7410-25 (limited supply), 00517-8201-25 (limited supply) 00517-9203-25 and 00517-9310-25. 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 regular 10 mL vial (NDC 00517-7410-25); MTE-5 Conc. 1 mL vial (NDC 00517-8201-25); MTE-4 ped. 3 mL vial (NDC 00517-9203-25); 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 (Revised 12/17/2014)

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. 6 & 9 month dating available for direct orders upon request. 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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