Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Ketorolac Tromethamine Injection
Status: Currently in Shortage
»Date first posted:
03/23/2018
»Therapeutic Categories: Analgesia/Addiction
Baxter Healthcare (Revised 03/01/2023)
Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
---|---|---|---|
Ketorolac Tromethamine Injection, USP, 30 mg/ mL. Single dose glass flip top vial - 25 units per carton (NDC 0338-0072-25) | Limited Supply, Recovery Q3 2023 | FOR INTRAVENOUS AND INTRAMUSCULAR USE. 30mg/mL (1 mL fill volume/ 2 mL container) | Third-party Supplier Issue |
Ketorolac Tromethamine Injection, USP, 15 mg/mL. Single dose glass flip top vial. 10 units per carton (NDC 0338-0069-10) | Available |
Fresenius Kabi USA, LLC (Revised 03/10/2023)
Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
---|---|---|---|
15 mg per mL, Single Dose, Simplist Syringe, (NDC 76045-107-10) | Backordered. Next release not available at this time. | Check wholesaler for inventory. | |
30 mg per mL, Single Dose, Simplist Syringe, (NDC 76045-104-10) | Available | Check wholesaler for inventory. | |
60 mg per 2 mL, Single Dose, Simplist Syringe, (NDC 76045-105-20) | Available | Check wholesaler for inventory | |
15 mg per mL, Single Dose Amber Vial, (NDC 63323-161-01) | Available | Check wholesaler for inventory | Manufacturing delays |
30 mg per mL, Single Dose Amber Vial, (NDC 63323-162-01) | Backordered. Next release April 2023. | Check wholesaler for inventory. | Manufacturing delays |
30 mg per mL, Single Dose Amber Vial, (NDC 63323-162-02) | Backordered. Next release May 2023. | Check wholesaler for inventory. | Manufacturing delays |
Gland Pharma Limited (Reverified 03/10/2023)
Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
---|---|---|---|
15 mg/mL vial (NDC 70860-700-01 and 70860-700-02) | Available | Demand increase for the drug | |
30 mg/mL vial (NDC 70860-701-01 and 70860-701-03) | Available | Demand increase for the drug | |
60 mg/mL vial (NDC 70860-701-02 and 70860-701-04) | Available | Demand increase for the drug | |
30 mg/mL, 1 mL vial (NDC 72266-118-25) | Available | Demand increase for the drug | |
30 mg/mL, 2 mL vial (NDC 72266-119-25) | Available | Available |
Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Reverified 10/13/2022)
Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
---|---|---|---|
15 mg/mL, 1 mL vial (NDC 0641-6041-25) | Unavailable, shortage recovery TBD. | Demand increase for the drug | |
30 mg/mL, 1 mL vial (NDC 0641-6042-25) | Unavailable, shortage recovery TBD. | Demand increase for the drug | |
30 mg/mL, 2 mL vial (NDC 0641-6043-25) | Unavailable, shortage recovery TBD. | Demand increase for the drug |
Hospira, Inc., a Pfizer company (Reverified 03/17/2023)
Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
---|---|---|---|
15 mg/mL (15 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3793-01) | Next Delivery: March 2023; Estimated Recovery: March 2024 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
30 mg/mL (30 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3795-01) | Next Delivery: March 2023; Estimated Recovery: March 2024 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
60 mg/2 mL (30 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3796-01) | Next Delivery: May 2023; Estimated Recovery: June 2023 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
Sagent Pharmaceuticals (Reverified 03/22/2023)
Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
---|---|---|---|
KETOROLAC TROMETHAMINE INJECTION 15MG/ML 25X1ML (NDC 25021-700-01) | Backordered. Estimated availability TBD | Manufacturing delays | |
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X2ML (NDC 25021-701-02) | Backordered. Estimated availability TBD | Manufacturing delay | |
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X1ML (NDC 25021-701-01) | Backordered. Estimated availability TBD | Manufacturing delay |
Virtus Pharmaceuticals (New 03/26/2018)
Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
---|---|---|---|
30MG/ML (NDC 69543-0386-25) | Available | Other |