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FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Rocuronium Bromide Injection
Status: Currently in Shortage
»Date first posted: 02/15/2023
»Therapeutic Categories: Anesthesia

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Almaject (New 02/27/2023)

Company Contact Information:
866-770-3024

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50mg/5mL multidose vial (NDC 72611-756-01) Available Gland is the application holder and Almaject is the distributor/labeler
100mg/10mL multidose vial (NDC 72611-757-01) Unavailable Gland is the application holder and Almaject is the distributor/labeler

Baxter Healthcare (Revised 03/01/2023)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg / 5 mL (5 mg / mL), Multiple Dose Vial, Product Code RCM0050 (NDC 04306-6007-10) Limited Supply, Recovery Q3 2023 Tamarang is the application holder and Baxter is the distributor/labeler Demand Increase
100 mg /10 mL (10 mg / mL), Multiple Dose Vial, Product Code RCM0100 (NDC 04306-6013-10) Limited Supply, Recovery March 2023 Tamarang is the application holder and Baxter is the distributor/labeler Demand Increase

Eugia Pharma Specialties LTD. (formerly Aurobindo) (Revised 03/17/2023)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
100mg/10mL (NDC 55150-226-10) Available
50mg/5mL (NDC 55150-225-05) Available

Fresenius Kabi USA, LLC (New 02/15/2023)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg per 50 mL (10 mg per mL), multiple dose vial, (NDC 63323-426-05) Backordered. Next release March 2023. Demand increase for the drug
100 mg per 10 mL (10 mg per mL), multiple dose vial, (NDC 63323-426-10) 1 month expiry (3/31/2023 expiry) dating available by request. Next release April 2023. Demand increase for the drug

Hikma Pharmaceuticals USA Inc. (New 02/24/2023)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mg/mL, 5 mL vial (NDC 0143-9250-10) This presentation is temporarily on backorder. Additional lots will be available in the March 2023 timeframe. Product will be made available as it is released. Demand increase for the drug
10 mg/mL, 10 mL vial (NDC 0143-9251-10) This presentation is temporarily on backorder. Additional lots will be available in the March - April 2023 timeframe. Product will be made available as it is released. Demand increase for the drug

Hospira, Inc., a Pfizer company (Revised 03/17/2023)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg/5 mL (10 mg/mL) Multiple Dose Glass Fliptop Vial (NDC 00409-9558-05) Limited Supply Available. Next Delivery: March 2023; Estimated Recovery: December 2024 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
50 mg/5 mL (10 mg/mL); 5 mL Multiple Dose Glass Fliptop Vial NovaPlus (NDC 00409-9558-49) Limited Supply Available. Next Delivery May 2023; Estimated Recovery: December 2024 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
100 mg/10 mL (10 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-9558-10) Limited Supply. Next Delivery: August 2024; Estimated Recovery: December 2024 Shortage per Manufacturer: Manufacturing Delay Other
100 mg/10 mL (10 mg/mL); 10 mL Multiple Dose Glass Fliptop Vial NovaPlus (NDC 00409-9558-50) Limited Supply Available. Next Delivery: May 2023; Estimated Recovery: December 2024 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other

Mylan Institutional, a Viatris Company (Reverified 03/14/2023)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg/5 mL solution in multi-dose vials (preservative-free) (NDC 67457-228-05) Available

Sagent Pharmaceuticals (Reverified 03/22/2023)

Company Contact Information:
866-625-1618

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg/5mL Pk 10 Vials (NDC 25021-662-05) Backordered. Availability: April 2023 Other
100 mg/10mL Pk 10 Vials (NDC 25021-662-10) Unavailable Other

Sandoz Inc. (Reverified 03/17/2023)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
10 mg/mL 10 mL vials, box of 10 (NDC 0781-3220-95) Intermittent Supply until Expected Recovery in July 2023 Other
10 mg/mL 5 mL vials, box of 10 (NDC 0781-3220-92) Intermittent Supply until Expected Recovery in July 2023 Other

XGen Pharmaceuticals DJB, Inc. (New 02/15/2023)

Company Contact Information:
866-390-4411

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg/5mL, box of 10 (NDC 39822-4200-2) Intermittent availability until October 2023 then steady supply Tamarang is the application holder and X-Gen is the distributor/labeler Demand increase for the drug
100 mg/10mL, box of 10 (NDC 39822-4200-6) Intermittent availability until October 2023 then steady supply Tamarang is the application holder and X-Gen is the distributor/labeler Demand increase for the drug
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