FDA Drug Shortages

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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Athenex Pharmaceutical Division, LLC (Athenex) (Revised 01/07/2019)

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 Available
30 mg/mL vial (NDC 70860-701-01 and 70860-701-03) Available Available
60 mg/mL vial (NDC 70860-701-02 and 70860-701-04) Available Available

Fresenius Kabi USA, LLC (Revised 02/06/2019)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
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 February 2019. Check wholesaler for inventory. Manufacturing delays
30 mg per mL, Single Dose Amber Vial, (NDC 63323-162-02) Backordered. Next release February 2019. Check wholesaler for inventory. Manufacturing delays

Hospira, Inc. (Reverified 02/15/2019)

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) Next Delivery and Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
30 mg/mL (30 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-2287-31) Next Delivery and Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
60 mg/2 mL (30 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-2287-61) Next Delivery and Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
15 mg/mL (15 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3793-01) Next Delivery and Estimated Recovery: February 2019 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) Available Other
60 mg/2 mL (30 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3796-01) Available Other

Sagent Pharmaceuticals (Reverified 02/15/2019)

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. Next release date not available at this time Manufacturing delay
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X2ML (NDC 25021-701-02) Available Manufacturing delay
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X1ML (NDC 25021-701-01) Backordered. Next release date not available at this time Available

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

West-Ward Pharmaceuticals (Revised 12/18/2018)

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) This presentation is temporarily on backorder. Additional lots are scheduled to be manufactured and available in the January - February 2019 timeframe. Product will be made available as it is released. Demand increase for the drug
30 mg/mL, 1 mL vial (NDC 0641-6042-25) Inventory is currently available. Additional lots are scheduled to be manufactured and available in the December 2018 timeframe. Product will be made available as it is released. Demand increase for the drug
30 mg/mL, 2 mL vial (NDC 0641-6043-25) Inventory is currently available. Additional lots will be scheduled for manufacturing as needed. Product will be made available as it is released. Demand increase for the drug

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