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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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 Tobramycin Solution for Injection

 Status: Currently in Shortage

 » Date first reported: No date available
 » Therapeutic Categories: Anti-Infective; Pediatric

Fresenius Kabi USA, LLC (Revised 11/07/2014)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mg/ml; 2ml vial (NDC 63323-0305-02) 6 & 7 months dating by request Demand increase for the drug
40 mg/mL, 2 mL vial (NDC 63323-0306-02) Available Check wholesalers for inventory Demand increase for the drug
40 mg/mL, 30 mL vial (NDC 63323-0306-30) Available Check wholesalers for inventory Demand increase for the drug
40 mg/mL, 50 mL vial (NDC 63323-0307-51) Backordered. Next release anticipated December 2014. Check wholesalers for inventory Demand increase for the drug
40 mg/mL, 2 mL Novaplus vial (NDC 63323-0306-55) Backordered. No estimated delivery at this time. Shortage per Manufacturer: Increase in demand/manufacturing delays Demand increase for the drug
40 mg/mL, 30 mL Novaplus vial (NDC 63323-0306-56) Backordered. No estimated delivery at this time. Check wholesalers for inventory Demand increase for the drug
1.2 gram 50 mL vial, preservative-free, 6 count (NDC 63323-0303-51) Available Check wholesalers for inventory Demand increase for the drug
1.2 gram 50 mL Novaplus vial, preservative-free, 6 count (NDC 63323-0303-55) Available Check wholesalers for inventory Demand increase for the drug

Hospira, Inc. (Reverified 11/19/2014)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
80 mg/mL in 0.9% NaCl; 100 mL (NDC 0409-3470-23) Next delivery and estimated recovery TBD Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing delay. Other
10 mg/mL; 2 mL vial (NDC 0409-3577-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
40 mg/mL; 2 mL vial (NDC 0409-3578-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
40 mg/mL; 50 mL vial (NDC 0409-3590-02) Next delivery and estimated recovery TBD Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing delay. Other

Mylan Institutional (Revised 11/12/2014)

Company Contact Information:
888-258-4199

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg/mL, 2 mL vial (NDC 67457-473-22) Unavailable. Estimated Recovery: January 2015 Increased demand
40 mg/mL, 30 mL vial (NDC 67457-428-30) Unavailable. Estimated Recovery: February 2015 Increased demand
40 mg/mL, 30 mL vial Novaplus 10's (NDC 67457-427-30) Unavailable. Estimated Recovery: February 2015 Increased demand

Teva Pharmaceuticals (Reverified 11/13/2014)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg/mL, 2 mL vial (NDC 00703-9402-04) All tobramycin 40 mg/mL solution for injection are on long term backorder. Estimated release date 2Q 2015. Shortage per manufacturer: Method remediation delays. Method remediation delays
40 mg/mL, 30 mL vial (NDC 00703-9416-01) All tobramycin 40 mg/mL solution for injection are on long term backorder. Estimated release date 2Q 2015. Shortage per manufacturer: Method remediation delays. Method remediation delays
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