FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Ondansetron Hydrochloride Injection
Status: Currently in Shortage
»Date first posted: 04/11/2018
»Therapeutic Categories: Gastroenterology

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Apotex Corp. (Reverified 11/15/2018)

Company Contact Information:
800-706-5575

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Ondansetron 2mg/mL 2mL vials Box of 25 vials (NDC 60505-6130-05) Available Available

Athenex Pharmaceutical Division, LLC (Athenex) (Reverified 10/22/2018)

Company Contact Information:
855-273-0154

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg/mL 2mL vial (NDC 70860-776-02) Available Available
2 mg/mL 20mL vial (NDC 70860-777-20) Available Available

AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 08/01/2018)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg/mL, 2 mL vial, 25 count (NDC 55150-125-02) Currently on backorder, next shipment expected early Sept. 2018 Intermittent availability expected Demand increase for the drug
2 mg/mL, 20 mL vial, 1 count (NDC 55150-126-20) Currently on backorder, next shipment TBD Intermittent availability expected Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 11/08/2018)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Single dose, amber vial, 4 mg per 2 mL (NDC 63323-373-02) Available Check wholesalers for inventory Demand increase for the drug
Multi dose, amber vial, 40 mg per 20 mL (NDC 63323-374-20) Backordered. Next release date not available at this time. Demand increase for the drug
Single dose, Simplist syringe, 4 mg per 2 mL (NDC 76045-103-20) Backordered. Next release Q1 - 2019. Demand increase for the drug

Heritage Pharma (Reverified 08/01/2018)

Company Contact Information:
866-901-1230

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Inj4mg/2mL, 25 (NDC 23155-549-31) Limited supply available Demand increase for the drug
PPRx4mg/2mL (NDC 23155-548-41) Limited supply available Demand increase for the drug
PPRx4mg/2mL (NDC 23155-548-42) Limited supply available Demand increase for the drug
4mg/2mL, 10 (NDC 23155-547-41 ) Limited supply available Demand increase for the drug

Hospira, Inc. (Revised 11/08/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg/20 mL (2 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-4759-01) Available Other
4 mg/2 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-4755-03) Limited Supply Available. Next Delivery: December 2018; Estimated Recovery: June 2019 Demand increase for the drug
4 mg/2 mL (2 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1120-12) Next Delivery and Estimated Recovery: December 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other

Sagent Pharmaceuticals (Reverified 11/15/2018)

Company Contact Information:
866-625-1618

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40mg/20mL EA 1 Vial (NDC 25021-782-20) Backordered. Next release date not available at this time Demand increase for the drug
4mg/2mL PK 25 Vials (NDC 25021-777-02) Backordered. Next release date not available at this time Manufacturing delay

West-Ward Pharmaceuticals (Revised 10/03/2018)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg/mL, 20 mL vial (NDC 0143-9890-01) This presentation is temporarily on backorder. Additional lots are scheduled to be manufactured and available in the November 2018 timeframe. Product will be made available as it is released. Demand increase for the drug
2 mg/mL, 2 mL vial (NDC 0641-6078-25) This presentation is temporarily on backorder. Additional lots are scheduled to be manufactured and available in the October 2018 timeframe. Product will be made available as it is released. Demand increase for the drug

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