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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 02/12/2021)

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

Caplin Steriles Limited (Revised 11/23/2022)

Company Contact Information:

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.2%, 40 mg/20 mL (2 mg/mL) single dose vial (NDC 43066-015-10) Limited Supply; Recovery February 2023 Demand increase
0.5%, 100 mg/20 mL (5 mg/mL) single dose vial (NDC 43066-019-10) Limited supply; Recovery March 2023 Demand increase
0.5%, 150 mg/30 mL (5 mg/mL) single dose vial (NDC 43066-023-10) Limited supply; Recovery February 2023 Demand increase
1%, 200 mg/20 mL (10 mg/mL) single dose vial (NDC 43066-027-10) Limited supply; Recovery February 2023 Demand increase

Eugia Pharma Specialties LTD. (formerly Aurobindo) (Revised 11/18/2022)

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 Sporadic availability expected. Shortage of active ingredient
0.2% 100 mL Single Dose Infusion Bottles (NDC 55150-196-99) Available Sporadic availability expected. Shortage of active ingredient
0.5% 20 mL Single Dose Vials (NDC 55150-197-20) Available Sporadic availability expected. Shortage of active ingredient
0.5% 30 mL Single Dose Vials (NDC 55150-198-30) Available Sporadic availability expected. Shortage of active ingredient
0.75% 20 mL Single Dose Vials (NDC 55150-199-20) Available Sporadic availability expected. Shortage of active ingredient
1% 10 mL Single Dose Vials (NDC 55150-200-10) Available Sporadic availability expected. Shortage of active ingredient
1% 20 mL Single Dose Vials (NDC 55150-201-20) Long-term backorder Sporadic availability expected. Shortage of active ingredient

Fresenius Kabi USA, LLC (Revised 11/14/2022)

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) Backordered. Next release not available at this time. Check wholesaler for inventory Available
2 mg per mL / 0.2% (40 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-285-20) Backordered. Next release not available at this time. Available
5 mg per mL / 0.5% (100 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-286-20) Backordered. Next release not available at this time. Available
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 Available
10 mg per mL / 1% (100 mg per 10 mL), Plastic Ampule, Sterile-Pak (63323-288-10) Backordered. Next release not available at this time. Available
10 mg per mL / 1% (200 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-288-20) Backordered. Next release not available at this time. Check wholesaler for inventory Available
2 mg per mL / 0.2% (200 mg per 100 mL), Single Dose Free Flex Bag (NDC 63323-285-61) Backordered. Next release not available at this time. Check wholesaler for inventory Available
2 mg per mL / 0.2% (400 mg per 200 mL), Single Dose Free Flex Bag (NDC 63323-285-63) Backordered. Next release not available at this time. Check wholesaler for inventory Available
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 delays
2 mg per mL / 0.2% (400 mg per 200 mL), Single Dose Infusion Bottle (NDC 63323-285-64) Available Check wholesaler for inventory Available
5 mg per mL / 0.5% (500 mg per 100 mL), Single Dose Infusion Bottle (NDC 63323-286-00) Available Check wholesaler for inventory Available
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 delays
2 mg per mL / 0.2% (20 mg per 10 mL), Single Dose Vial (NDC 63323-285-13) Available Check wholesaler for inventory Available
2 mg per mL / 0.2% (40 mg per 20 mL), Single Dose Vial (NDC 63323-285-23) Available Check wholesaler for inventory Manufacturing delays
5 mg per mL / 0.5% (150 mg per 30 mL), Single Dose Vial (NDC 63323-286-35) Available Check wholesaler for inventory Available
5 mg per mL / 0.5% (100 mg per 20 mL), Single Dose Vial (NDC 63323-286-23) Available Check wholesaler for inventory Manufacturing delays
7.5 mg per mL / 0.75% (150 mg per 20 mL), Single Dose Vial (NDC 63323-287-21) Backordered. Next release not available at this time. Check wholesaler for inventory Available
10 mg per mL / 1% (100 mg per 10 mL), Single Dose Vial (NDC 63323-288-11) Backordered. Next release November 2022. Check wholesaler for inventory Available
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 not available at this time.

InfoRLife SA (Revised 10/14/2022)

Company Contact Information:
Sagent: 866-625-1618

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.2% 2mg/mL 10x100mL (NDC 25021-671-82) Available Marketed by Sagent Pharmaceuticals
0.2% 2mg/mL 10x200mL (NDC 25021-671-87) Available Marketed by Sagent Pharmaceuticals
500 mg per 100 mL (5 mg per mL 0.5%) (NDC 25021-652-82 ) Backordered. Estimated availability November 2022 Marketed by Sagent Pharmaceuticals Other
1,000 mg per 200 mL (5 mg per mL 0.5%) (NDC 25021-652-87) Backordered. Estimated availability October 2022 Marketed by Sagent Pharmaceuticals Other
0.2% 2mg/mL 10x100mL (NDC 25021-671-66), Novaplus Available Marketed by Sagent Pharmaceuticals
0.2% 2mg/mL 10x200mL (NDC 25021-671-67), Novaplus Available Marketed by Sagent Pharmaceuticals

Somerset Therapeutics, LLC (New 04/20/2022)

Company Contact Information:
732-554-1019

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5% (5 mg/mL), 30 mL, 1 vial (NDC 70069-064-01) Available
0.5% (5 mg/mL), 30 mL, 10 vials (NDC 70069-064-10) Available
0.5% (5 mg/mL), 30 mL, 25 vials (NDC 70069-064-25) Available
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