FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Ropivacaine Hydrochloride injection
Status: Currently in Shortage
»Date first posted: 03/23/2018
»Therapeutic Categories: Anesthesia

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Akorn Pharmaceuticals (Revised 07/06/2018)

Company Contact Information:
800-932-5676

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5% 5mg/mL, 30mL, 1 Vial (NDC 17478-0081-30) Available Other

AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 08/20/2018)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.2% 20 mL Single Dose Vials (NDC 55150-195-20) Available Demand increase for the drug
0.2% 100 mL Single Dose Infusion Bottles (NDC 55150-196-99) Available Demand increase for the drug
0.5% 20 mL Single Dose Vials (NDC 55150-197-20) Available Demand increase for the drug
0.5% 30 mL Single Dose Vials (NDC 55150-198-30) Available Demand increase for the drug
0.75% 20 mL Single Dose Vials (NDC 55150-199-20) Available Demand increase for the drug
1% 10 mL Single Dose Vials (NDC 55150-200-10) Currently backordered Next shipment expected late August Demand increase for the drug
1% 20 mL Single Dose Vials (NDC 55150-201-20) Currently available Next shipment TBD Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 11/28/2018)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2 mg per mL / 0.2% (20 mg per 10 mL), Plastic Ampule, Sterile-Pak (NDC 63323-285-10) Available Check wholesaler for inventory Manufacturing Delay
2 mg per mL / 0.2% (40 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-285-20) Available Check wholesaler for inventory Manufacturing Delay
5 mg per mL / 0.5% (100 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-286-20) Available Check wholesaler for inventory Manufacturing Delay
7.5 mg per mL / 0.75% (150 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-287-20) Available Check wholesaler for inventory Manufacturing Delay
10 mg per mL / 1% (100 mg per 10 mL), Plastic Ampule, Sterile-Pak (63323-288-10) Available Check wholesaler for inventory Manufacturing Delay
10 mg per mL / 1% (200 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-288-20) Available Check wholesaler for inventory Manufacturing Delay
2 mg per mL / 0.2% (200 mg per 100 mL), Single Dose Free Flex Bag (NDC 63323-285-61) Backordered. Next release January 2019. Check wholesaler for inventory Manufacturing Delay
2 mg per mL / 0.2% (400 mg per 200 mL), Single Dose Free Flex Bag (NDC 63323-285-63) Available Check wholesaler for inventory Manufacturing Delay
2 mg per mL / 0.2% (200 mg per 100 mL), Single Dose Infusion Bottle (NDC 63323-285-65) Available Check wholesaler for inventory Manufacturing Delay
2 mg per mL / 0.2% (400 mg per 200 mL), Single Dose Infusion Bottle (NDC 63323-285-64) Available Check wholesaler for inventory Manufacturing Delay
5 mg per mL / 0.5% (500 mg per 100 mL), Single Dose Infusion Bottle (NDC 63323-286-00) Backordered. Next release December 2018. Check wholesaler for inventory Manufacturing Delay
5 mg per mL / 0.5% (1,000 mg per 200 mL), Single Dose Infusion Bottle (NDC 63323-286-63) Available Check wholesaler for inventory Manufacturing Delay
2 mg per mL / 0.2% (20 mg per 10 mL), Single Dose Vial (NDC 63323-285-13) Available Check wholesaler for inventory Manufacturing Delay
2 mg per mL / 0.2% (40 mg per 20 mL), Single Dose Vial (NDC 63323-285-23) Available Check wholesaler for inventory Manufacturing Delay
5 mg per mL / 0.5% (150 mg per 30 mL), Single Dose Vial (NDC 63323-286-35) Available Check wholesaler for inventory Manufacturing Delay
5 mg per mL / 0.5% (100 mg per 20 mL), Single Dose Vial (NDC 63323-286-23) Available Check wholesaler for inventory Manufacturing Delay
7.5 mg per mL / 0.75% (150 mg per 20 mL), Single Dose Vial (NDC 63323-287-21) Available Check wholesaler for inventory Manufacturing Delay
10 mg per mL / 1% (100 mg per 10 mL), Single Dose Vial (NDC 63323-288-11) Available Check wholesaler for inventory Manufacturing Delay
10 mg per mL / 1% (200 mg per 20 mL), Single Dose Vial (NDC 63323-288-21) Available Check wholesaler for inventory Manufacturing Delay
5 mg per mL / 0.5% (150 mg per 30 mL), Sterile-Pack, Single Dose Vial (NDC 63323-286-31) Backordered. Next release January 2019. Manufacturing Delay

Hospira, Inc. (Reverified 12/06/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
20 mg/10 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9300-10) Available Other
40 mg/20 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9300-20) Available Other
150 mg/30 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9301-30) Available Other
150 mg/20 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9302-20) Available Other
100 mg/10 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9303-10) Available Other
200 mg/20 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9303-20) Available Other

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