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: 04/10/2018
»Therapeutic Categories: Gastroenterology

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AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (New 04/11/2018)

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 TBD Intermittent backorders 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 backorders expected Demand increase for the drug

Fresenius Kabi USA, LLC (Reverified 04/23/2018)

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) Backordered. Next release anticipated May 2018. 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) Backordered. Next release anticipated June 2018. Demand increase for the drug

Heritage Pharma (New 04/11/2018)

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 04/20/2018)

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); 20 mL Multiple Dose Glass Fliptop Vial (NDC 00409-4759-01) Available Available Other
4 mg/2 mL (2 mg/mL); 2 mL Single Dose Glass Fliptop Vial (NDC 00409-4755-03) Next delivery: Mid-May 2018. Estimated recovery: June 2018 Shortage per manufacturer: Manufacturing Delay Other
4 mg/2 mL (2 mg/mL); 2 mL iSecure Luer Lock Glass Syringe (NDC 00409-1120-12) Next delivery: June 2019. Estimated recovery: June 2019 Shortage per manufacturer: Manufacturing Delay

Dear Customer Letter

Other

West-Ward Pharmaceuticals (Revised 04/18/2018)

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) West-Ward has available inventory. Additional lots are scheduled to be manufactured and available in the May - June 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 April - May 2018 timeframe. Product will be made available as it is released. Demand increase for the drug

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