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 09/17/2018)

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) On allocation Demand increase for the drug
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 (Reverified 10/15/2018)

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) 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

Hospira, Inc. (Revised 10/11/2018)

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: December 2019; 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) Available 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 10/18/2018)

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. Availability TBD Manufacturing delay
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X2ML (NDC 25021-701-02) On backorder. Availability TBD Manufacturing delay
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X1ML (NDC 25021-701-01) On backorder. Availability TBD 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 (Reverified 09/10/2018)

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 August - September 2018 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 August - September 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 are scheduled to be manufactured and available in the August - September 2018 timeframe. Product will be made available as it is released. Demand increase for the drug

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