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 09/18/2019)

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

AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 06/25/2019)

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 early September 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 early September 2019 Intermittent availability expected Demand increase for the drug

Baxter Healthcare (Reverified 09/05/2019)

Company Contact Information:
800-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Ondansetron Injection, USP (2 mg/mL) 2 mL Single Use Glass Vial (25 x 2 mL) (NDC 36000-012-25) Available For IV or IM injection

Fresenius Kabi USA, LLC (Reverified 09/17/2019)

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) Backordered. Next release date not availabe at this time. 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

Gland Pharma (Revised 08/30/2019)

Company Contact Information:
609-250-7990

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg/mL 2mL vial (NDC 70860-776-02) Available Marketed by Athenex. To order, contact Athenex at 855-273-0154 Available
2 mg/mL 20mL vial (NDC 70860-777-20) Available Marketed by Athenex. To order, contact Athenex at 855-273-0154 Available
2 mg/mL, 2 mL vial (NDC 72266-123-25) Available Distributed by Fosun Pharma USA Inc. Company Contact Information: 833-291-9645 Available
2 mg/mL, 20 mL vial (NDC 72266-124-01) Available Distributed by Fosun Pharma USA Inc. Company Contact Information: 833-291-9645 Available

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

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 04/25/2019)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg/mL, 2 mL vial (NDC 0641-6078-25) Inventory is currently available Product is scheduled for release the first week of May 2019 Demand increase for the drug
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

Hospira, Inc. (Reverified 09/10/2019)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4 mg/2 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-4755-03) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
4 mg/2 mL (2 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1120-12) Next Delivery and Estimated Recovery: August 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
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

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other

Sagent Pharmaceuticals (Revised 09/13/2019)

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

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