FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Tobramycin Injection
Status: Currently in Shortage
»Date first posted: No date available
»Therapeutic Categories: Anti-Infective; Pediatric

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

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) 7 month dating available by request. Next release anticipated July 2016. Check wholesalers for inventory 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) Backordered. Next release anticipated July 2016. Check wholesalers for inventory Demand increase for the drug
40 mg/mL, 50 mL vial (NDC 63323-0307-51) Backordered. Next release anticipated August 2016. Demand increase for the drug
40 mg/mL, 2 mL Novaplus vial (NDC 63323-0306-55) Backordered. No estimated delivery at this time. Demand increase for the drug
40 mg/mL, 30 mL Novaplus vial (NDC 63323-0306-56) Backordered. No estimated delivery at this time. Demand increase for the drug
Powder for solution, 1.2 gram 50 mL vial, preservative-free, 6 count (NDC 63323-0303-51) Backordered. Next release anticipated July 2016. Demand increase for the drug
Powder for solution, 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. (Revised 07/14/2016)

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) Discontinued Discontinuation of the manufacturer of the drug
10 mg/mL; 2 mL vial (NDC 0409-3577-01) Next delivery and estimated recovery TBD. Discontinued 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) Discontinued Discontinuation of the manufacturer of the drug

Mylan Institutional (Revised 07/19/2016)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg/mL, 2 mL vial (NDC 67457-473-22) Available Demand increase for the drug
40 mg/mL, 30 mL vial (NDC 67457-428-30) Available Demand increase for the drug
40 mg/mL, 30 mL vial Novaplus 10's (NDC 67457-427-30) Unavailable. Estimated Recovery: TBD Demand increase for the drug
40 mg/mL, 2 mL vial NOVAPLUS (NDC 67457-432-02) Unavailable. Estimated Recovery: TBD 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)
40 mg/mL, 2 mL vial (NDC 00703-9402-04) Teva expects to have product available Q4'16 Method remediation delays
40 mg/mL, 30 mL vial (NDC 00703-9416-01) Teva expects to have product available Q4'16 Method remediation delays

X-GEN Pharmaceuticals, INC (New 01/22/2015)

Company Contact Information:
866-390-4411

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Powder for solution, 1.2gm/pharmacy bulk pack 6 pack carton (NDC 39822-0412-6) Both sizes are in stock and being distributed. No shortages are expected Available Other
Powder for solution, 1.2gm/pharmacy bulk pack Single vial carton (NDC 39822-0412-1) Both sizes are in stock and being distributed. No shortages are expected Available Other

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