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
Almaject (New 02/27/2023)
| 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 06/07/2023)
| 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 43066-007-10) | Limited Supply, Recovery June 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 43066-013-10) | Limited supply; Recovery December 2023 | Tamarang is the application holder and Baxter is the distributor/labeler | Demand Increase |
Eugia Pharma Specialties LTD. (formerly Aurobindo) (Revised 05/31/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 100mg/10mL (NDC 55150-226-10) | Currently on backorder - next shipment June 2023 | Check wholesalers for inventory | Demand increase for the drug |
| 50mg/5mL (NDC 55150-225-05) | Available | Check wholesalers for inventory | Available |
Fresenius Kabi USA, LLC (New 02/15/2023)
| 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)
| 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. (Revised 05/31/2023)
| 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 0409-9558-05) | Limited Supply Available. Next Delivery: July 2023; Estimated Recovery: December 2023 | 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 0409-9558-49) | Limited Supply Available. Next Delivery: July 2023; Estimated Recovery: December 2023 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 100 mg/10 mL (10 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 0409-9558-10) | Next Delivery: June 2023; Estimated Recovery: December 2023 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 100 mg/10 mL (10 mg/mL); 10 mL Multiple Dose Glass Fliptop Vial NovaPlus (NDC 0409-9558-50) | Limited Supply Available. Next Delivery and Estimated Recovery: June 2023 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
Mylan Institutional, a Viatris Company (Reverified 06/07/2023)
| 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 | ||
| 100 mg/10 ml solution in multi-dose vials (preservative-free) (NDC 67457-228-10) | Available |
Sagent Pharmaceuticals (Reverified 05/15/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 50 mg/5mL Pk 10 Vials (NDC 25021-662-05) | Backordered. Availability: May 2023 | Other | |
| 100 mg/10mL Pk 10 Vials (NDC 25021-662-10) | Unavailable | Other |
Sandoz Inc. (Reverified 05/26/2023)
| 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)
| 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 |