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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

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Baxter Healthcare (Revised 09/28/2022)

Company Contact Information:
888-229-0001

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) Available
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 09/14/2022)

Company Contact Information:
888-386-1300

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) Available Check wholesaler for inventory. Manufacturing delays
30 mg per mL, Single Dose Amber Vial, (NDC 63323-162-02) Available Check wholesaler for inventory. Manufacturing delays

Gland Pharma Limited (Reverified 09/28/2022)

Company Contact Information:
855-273-0154

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 04/08/2022)

Company Contact Information:
800-631-2174

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. (Revised 09/12/2022)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
30 mg/mL (30 mg/mL); iSecure Luer Lock Glass Syringe (NDC 00409-2287-23) Discontinued Discontinuation of the manufacture of the drug
30 mg/mL (30 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-2287-31) Discontinued Discontinuation of the manufacture of the drug
60 mg/2 mL (30 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-2287-61) Discontinued Discontinuation of the manufacture of the drug
15 mg/mL (15 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3793-01) Limited Supply Available. Next Delivery: October 2022; Estimated Recovery: November 2022 Demand increase for the drug
30 mg/mL (30 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3795-01) Next Delivery: October 2022; Estimated Recovery: November 2022 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) Limited Supply Available. Next Delivery: September 2022; Estimated Recovery: January 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Demand increase for the drug

Sagent Pharmaceuticals (Reverified 08/22/2022)

Company Contact Information:
866-625-1618

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)

Company Contact Information:
888-843-3593

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
30MG/ML (NDC 69543-0386-25) Available Other
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