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 04/18/2019)

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 04/22/2019)

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 03/05/2019)

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 mid-May 2019 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 expected mid-May 2019 Intermittent availability expected Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 04/16/2019)

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) Available Check wholesalers for inventory Demand increase for the drug
Single dose, Simplist syringe, 4 mg per 2 mL (NDC 76045-103-20) Available Check wholesalers for inventory 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 04/09/2019)

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) Next Delivery: September 2019; Estimated Recovery: October 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
4 mg/2 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-4755-03) Limited Supply Available. Next Delivery: April 2019; Estimated Recovery: May 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
4 mg/2 mL (2 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1120-12) Next Delivery: September 2019; Estimated Recovery: January 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other

Sagent Pharmaceuticals (Reverified 04/18/2019)

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. Estimated availability Aug-2019 Demand increase for the drug
4mg/2mL PK 25 Vials (NDC 25021-777-02) Backordered. Estimated availability July-2019 Manufacturing delay

West-Ward Pharmaceuticals (Revised 12/18/2018)

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) Inventory is currently available. Additional lots will be scheduled for manufacturing as needed. Product will be made available as it is released. Demand increase for the drug
2 mg/mL, 2 mL vial (NDC 0641-6078-25) Inventory is currently available. Additional lots will be scheduled for manufacturing as needed. Product will be made available as it is released. Demand increase for the drug

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