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 10/15/2018)

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 October 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) Available Check wholesalers for inventory 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
1 mg per 1 mL, Single dose vial, (NDC 63323-852-25) Backordered. Next release October 2018. Check wholesalers for inventory Demand increase for the drug
2 mg per 1 mL, Single dose vial, (NDC 63323-853-25) Available Check wholesalers for inventory Demand increase for the drug
4 mg per 1 mL, Single dose vial, (NDC 63323-854-10) Backordered. Next release December 2018. Check wholesalers for inventory Demand increase for the drug
10 mg per 1 mL, Single dose vial, high potency formulation (HPF), (NDC 63323-851-10) Backordered. Next release not available at this time. Check wholesalers for inventory Demand increase for the drug
50 mg per 5 mL, Single dose vial, high potency formulation (HPF), (NDC 63323-851-15) Backordered. Next release not available at this time. Check wholesalers for inventory Demand increase for the drug
500 mg per 50 mL, Single dose vial, high potency formulation (HPF), (NDC 63323-851-50) Available Check wholesalers for inventory Demand increase for the drug

Hospira, Inc. (Revised 10/11/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5 mg/0.5 mL (1 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1283-05) Next Delivery: March 2019; Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
1 mg/1 mL (1 mg/1 mL); iSecure Luer Lock Glass Syringe (NDC 00409-1283-10) Next Delivery: June 2019; Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
2 mg/1 mL (2 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-1312-10) Next Delivery: June 2019; Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
1 mg/1 mL (1 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1283-31) Next Delivery and Estimated Recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Health Care Provider

Other
2 mg/1 mL (2 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1312-30) Next Delivery: TBD; Estimated Recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Health Care Provider

Other
4 mg/1 mL (4 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-1304-31) Next Delivery: December 2019; Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
1 mg/1 mL (1 mg/mL); Glass Ampul (NDC 00409-2552-01) Next Delivery and Estimated Recovery: TBD Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
2 mg/1 mL (2 mg/mL); Glass Ampul (NDC 00409-3356-01) Next Delivery: October 2018; Estimated Recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Health Care Provider Letter

Other
4 mg/1 mL (4 mg/mL); Glass Ampul (NDC 00409-2540-01) Next Delivery and Estimated Recovery: TBD Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
2 mg/1 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3365-01) Next Delivery: September 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 00409-2634-01) Next Delivery: Early November 2018; Estimated Recovery: December 2018 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
50 mg/5 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2634-05) Next Delivery: Early November 2018; Estimated Recovery: March 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
500 mg/50 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2634-50) Next Delivery and Estimated Recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other

Teva Pharmaceuticals (Reverified 10/11/2018)

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 09/10/2018)

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) Inventory is currently available. Additional lots are scheduled to be manufactured in the October 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) Inventory is currently available. Additional lots are scheduled to be manufactured in the October 2018 timeframe. Product will be made available as it is released. Demand increase for the drug

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