FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Hydromorphone Hydrochloride Injection, USP
Status: Currently in Shortage
»Date first posted: 10/31/2017
»Therapeutic Categories: Analgesia/Addiction

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Akorn Pharmaceuticals (Revised 03/23/2018)

Company Contact Information:
800-932-5676

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mg/mL, 1 mL ampule, 10 count (NDC 17478-0540-01) On allocation Demand increase for the drug
10 mg/mL, 5 mL ampule, 10 count (NDC 17478-0540-05) On allocation Demand increase for the drug
10 mg/mL, 50 mL vial, 10 count (NDC 17478-0540-50) On allocation Demand increase for the drug

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

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
(Dilaudid) 0.5 mg per 0.5 mL, prefilled syringe (NDC 76045-009-05) Backordered. Ongoing intermittent releases - next release anticipated April 2018. All Hydromorphone presentations are on intermittent back order and will be released to the wholesaler channel as the product becomes available. Check wholesalers for inventory. Demand increase for the drug
(Dilaudid) 1 mg per 1 mL, prefilled syringe (NDC 76045-009-10) Backordered. Next release date not available at this time. Demand increase for the drug
(Dilaudid) 2 mg per 1 mL, prefilled syringe (NDC 76045-010-10) Backordered. Next release date not available at this time. Demand increase for the drug
(Dilaudid) 4 mg per 1 mL, prefilled syringe (NDC 76045-011-10) Backordered. Next release date not available at this time. 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)
0.5 mg/0.5 mL iSecure™ Luer Lock Glass Syringe (no needle) (NDC 0409-1283-05) Next delivery: TBD; Estimated recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
1 mg/mL iSecure™ Luer Lock Glass Syringe (no needle) (NDC 0409-1283-10) Next delivery & Estimated recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
2 mg/mL iSecure™ Luer Lock Glass Syringe (no needle) (NDC 0409-1312-10) Next delivery & Estimated recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
1 mg/mL Carpuject™ Luer Lock Glass Syringe (no needle) (NDC 0409-1283-31) Next delivery: TBD; Estimated recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
2 mg/mL Carpuject™ Luer Lock Glass Syringe (no needle) (NDC 0409-1312-30) Next delivery: TBD; Estimated recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
4 mg/mL Carpuject™ Luer Lock Glass Syringe (no needle) (NDC 0409-1304-31) Next delivery & Estimated recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
1 mg/mL Glass Ampul (NDC 0409-2552-01) Next delivery & Estimated recovery: TBD Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
2 mg/mL Glass Ampul (NDC 0409-3356-01) Next delivery & Estimated recovery: TBD Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
4 mg/mL Glass Ampul (NDC 0409-2540-01) Next delivery & Estimated recovery: TBD Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
2 mg/mL Single Dose Glass Fliptop Vial (NDC 0409-3365-01) Next delivery: Late April 2018; Estimated recovery: March 2019 Check Wholesaler for Availability. Shortage per Manufacturer: Manufacturing Delay Other
10 mg/mL (10 mg/mL) Single Dose Glass Fliptop Vial (NDC 0409-2634-01) Next delivery: Late April 2018; Estimated recovery: March 2019 Check Wholesaler for Availability. Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
10 mg/mL (50 mg/5 mL) Single Dose Glass Fliptop Vial (NDC 0409-2634-05) Next Delivery: September 2018; Estimated recovery: March 2019 Check Wholesaler for Availability. Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
10 mg/mL (500 mg/50 mL) Single Dose Glass Fliptop Vial (NDC 0409-2634-50) Next Delivery: Late June 2018; Estimated recovery: March 2019 Check Wholesaler for Availability. Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other

Teva Pharmaceuticals (Revised 04/10/2018)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 MG/1ML (NDC0703-0110-03) Teva has limited quantities and product is being allocated. Periodic backorders are anticipated. Duration of the limited supply is unknown at this time. Other
10 MG/1ML (NDC 0703-0113-03) Teva has limited quantities and product is being allocated. Periodic backorders are anticipated. Duration of the limited supply is unknown at this time. Other
10 MG/1 ML (NDC 0703-0018-01) Teva has limited quantities and product is being allocated. Periodic backorders are anticipated. Duration of the limited supply is unknown at this time. Other

West-Ward Pharmaceuticals (Revised 03/23/2018)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg/mL, 1 mL vial (NDC 0641-0121-25) This presentation is temporarily on backorder. Additional lots are scheduled to be manufactured in the March - April 2018 timeframe. Product will be made available as it is released. Demand increase for the drug
2 mg/mL, 20 mL vial (NDC 0641-2341-41) This presentation is temporarily on backorder. Additional lots are scheduled to be manufactured in the March - April 2018 timeframe. Product will be made available as it is released. Demand increase for the drug

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