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) (Reverified 07/22/2019)

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 08/01/2019)

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

Gland Pharma (New 08/13/2019)

Company Contact Information:
609-250-7990

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
30 mg/mL, 1 mL vial (NDC 72266-118-25) Available Distributed by Fosun Pharma USA Inc. (Company Contact Information: 833-291-9645) Available
30 mg/mL, 2 mL vial (NDC 72266-119-25) Available Distributed by Fosun Pharma USA Inc. (Company Contact Information: 833-291-9645) Available

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 06/28/2019)

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 Demand increase for the drug
30 mg/mL, 1 mL vial (NDC 0641-6042-25) This presentation is temporarily on backorder Demand increase for the drug
30 mg/mL, 2 mL vial (NDC 0641-6043-25) This presentation is temporarily on backorder Demand increase for the drug

Hospira, Inc. (Revised 08/14/2019)

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: August 2020; Estimated Recovery: June 2021 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
30 mg/mL (30 mg/mL); Carpuject Luer Lock Glass Syringe (NDC 00409-2287-31) Next Delivery: September 2019; Estimated Recovery: December 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

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

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
15 mg/mL (15 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3793-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
30 mg/mL (30 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3795-01) Next Delivery: July 2019; Estimated Recovery: August 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
60 mg/2 mL (30 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-3796-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other

Sagent Pharmaceuticals (Reverified 08/19/2019)

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. Estimated availability October 2019 Manufacturing delays
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X2ML (NDC 25021-701-02) Backordered. Estimated availability October 2019 Manufacturing delay
KETOROLAC TROMETHAMINE INJECTION 30MG/ML 25X1ML (NDC 25021-701-01) Backordered. Estimated availability October 2019 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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