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) (New 03/23/2018)

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

Fresenius Kabi USA, LLC (Revised 04/03/2018)

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) Backordered. Next release anticipated April 2018. 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

Hospira, Inc. (Revised 04/13/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
30 mg/mL; 1 mL iSecure syringe (NDC 00409-2287-23) Next delivery: June 2019 Estimated recovery: June 2019 Shortage per manufacturer: Manufacturing Delay Other
30 mg/mL; 1 mL Carpuject syringe (NDC 00409-2287-31) Next delivery: June 2019 Estimated recovery: June 2019 Shortage per manufacturer: Manufacturing Delay Other
60 mg/2 mL (30 mg/mL); 2 mL Carpuject syringe (NDC 00409-2287-61) Next delivery: June 2019 Estimated recovery: June 2019 Shortage per manufacturer: Manufacturing Delay Other
15 mg/mL; 1 mL Single Dose Fliptop Vial (NDC 00409-3793-01) Next delivery: Late April 2018 Estimated recovery: June 2018 Check Wholesaler for Availability. Shortage per Manufacturer: Manufacturing Delay Other
30 mg/mL; 1 mL Single Dose Fliptop Vial (NDC 00409-3795-01) Next delivery: Mid April 2018 Estimated recovery: June 2018 Check Wholesaler for Availability. Shortage per Manufacturer: Manufacturing Delay Other
60 mg/2 mL (30 mg/mL); 2 mL Single Dose Fliptop Vial (NDC 00409-3796-01) Available Available Other

Sagent Pharmaceuticals (Revised 04/13/2018)

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) On backorder. Estimated availability June 2018 Manufacturing delay
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X2ML (NDC 25021-701-02) On backorder. Estimated availability April 2018 Manufacturing delay
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X1ML (NDC 25021-701-01) On backorder. Estimated availability June 2018 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

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