FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Rocuronium Bromide Injection
Status: Currently in Shortage
»Date first posted: 03/22/2017
»Therapeutic Categories: Anesthesia

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AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (New 04/26/2017)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg per 5 mL, multi dose vial (NDC 55150-225-05) Estimated availability early June 2017. Recently approved ANDA (4/12/2017) Other
100 mg per 10 mL, multi dose vial (NDC 55150-226-10) Estimated availability early June 2017. Recently approved ANDA (4/12/2017) Other

Fresenius Kabi USA, LLC (Reverified 04/28/2017)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg per 5 mL, multi dose vial (NDC 63323-426-05) Backordered. Next release anticipated July 2017. Shortage of an active ingredient
100 mg per 10 mL, multi dose vial (NDC 63323-426-10) Backordered. Next release anticipated July 2017. Shortage of an active ingredient

Hospira, Inc. (Revised 04/21/2017)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mg/mL; 50 mg/5 mL Multiple Dose Glass Fliptop Vial (NDC 0409-9558-05) Next delivery: Late May 2017. Estimated recovery: 2Q 2017 Limited Supply. Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing Delay Other
10 mg/mL; 100 mg/10 mL Multiple Dose Glass Fliptop Vial (NDC 0409-9558-10) Next delivery: Late May 2017. Estimated recovery: 2Q 2017 Limited Supply. Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing Delay Other

Mylan Institutional (Reverified 04/25/2017)

Company Contact Information:
888-258-4199

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50mg/5mL Pkg of 10 (NDC 67457-228-05) Available Available Demand increase for the drug
100mg/10mL Pkg of 10 (NDC 67457-228-10) Available Available Demand increase for the drug

Sagent Pharmaceuticals (New 03/23/2017)

Company Contact Information:
866-625-1618

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
100 mg/10 mL pack of 10 vials (NDC 25021066210) On backorder. Estimated availability: TBD Demand increase for the drug
50 mg/5 mL pack of 10 vials (NDC 25021066205) On backorder. Estimated availability: April 2017 Demand increase for the drug

Sandoz (Revised 04/27/2017)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mg/mL; 5 mL (NDC 0781-3220-92) Product available; Backorder end of May to be recovered in June 2017. Other
10 mg/mL; 10 mL (NDC 0781-3220-95) Product temporarily unavailable. Estimated recovery: end of June/July 2017. Other

X-GEN Pharmaceuticals, Inc. (New 03/23/2017)

Company Contact Information:
866-390-4411

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg/5 mL (NDC 39822-4200-1) (Vial) and (NDC 39822-4200-2)(Carton of 10) Estimated Availability: last week of March 2017 Demand increase for the drug
100 mg/10 mL (NDC 39822-4200-5) (Vial) and (NDC 39822-4200-6)(Carton of 10) Estimated Availability: last week of April 2017 Demand increase for the drug

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