Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Methotrexate Injection
Status: Currently in Shortage
»Date first posted:
03/13/2023
»Therapeutic Categories: Rheumatology; Oncology
Accord Healthcare Inc. (New 03/14/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 50 mg/2 mL (25 mg/mL) Single Dose Vial (NDC 16729-277-30) | Inventory on Hold Pending Further Assessment | Other | |
| 250 mg/10 mL (25 mg/mL) Single Dose Vial (NDC 16729-277-03) | Inventory on Hold Pending Further Assessment | Other | |
| 1 g/40 mL (25 mg/mL) Single Dose Vial (NDC 16729-277-35) | Inventory on Hold Pending Further Assessment | Other |
Fresenius Kabi USA, LLC (Reverified 05/31/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1g per vial; single dosage vial; (NDC 63323-122-50) | Backordered. Next release May 2023. | Demand Increase for the drug | |
| 250 mg per 10 mL (25 mg per mL); vial; (NDC 63323-123-10) | Backordered. Next release June 2023. | Check wholesalers for inventory. | Demand Increase for the drug |
Hikma Pharmaceuticals USA Inc. (New 03/15/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1 gram per vial (NDC 0143-9830-01) | 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 |
| 25 mg/mL, 2 mL vial (NDC 0143-9519-10) | 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 |
Hospira, Inc. (Revised 05/31/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 50 mg/2 mL (25 mg/mL) Multiple Dose Vial (NDC 61703-0350-38) | Limited Supply Available. Next Delivery: June 2023; Estimated Recovery: December 2023 | Demand Increase for the drug | |
| 50 mg/2 mL (25 mg/mL) Glass Fliptop Vial Novaplus® (NDC 61703-0350-10) | Limited Supply Available. Next Delivery: June 2023; Estimated Recovery: December 2023 Estimated recovery: September 2023 | Demand Increase for the drug | |
| 1 g/40 mL (25 mg/mL) Single Dose Glass Fliptop Vial (NDC 61703-0408-41) | Limited Supply Available. Next Delivery: June 2023; Estimated Recovery: December 2023 | Demand Increase for the drug | |
| 1 g/40 mL (25 mg/mL) Single Dose Glass Fliptop Vial Novaplus® (NDC 61703-0408-25) | Limited Supply Available. Next Delivery: September 2023; Estimated Recovery: December 2023 | Demand Increase for the drug | |
| 1 g/40 mL (25 mg/mL) Single-Dose Vial PREMIERProRx® (NDC 61703-0124-40) | Next Delivery: October 2023; Estimated Recovery: December 2023 | Demand Increase for the drug |
Teva Pharmaceuticals (Revised 05/23/2023)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 50 mg/2 mL (25 mg/mL) 2 mL Single-Dose Vial (NDC 0703-3671-01) | Unavailable; Recovery Estimated in May 2023 | Other | |
| 250 mg/10 mL (25 mg/mL) 10 mL Single-Dose Vial (NDC 0703-3675-01) | Allocating Available Supply, Recovery Estimated in June 2023 | Other | |
| 1 g/40 mL (25 mg/mL) 40 mL Single-Dose Vial (NDC 0703-3678-01) | Unavailable; Recovery Estimated in December 2023 | Other |