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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Bupivacaine Hydrochloride Injection
Status: Currently in Shortage
»Date first posted: 02/20/2018
»Therapeutic Categories: Anesthesia

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Areva Pharmaceuticals, Inc. (Revised 12/09/2021)

Company Contact Information:
812-399-3599, Option # 1

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.25% 5 mL single-dose ampules (NDC 59923-717-05) Available

Dear Health Care Provider Letter

0.25% 10 mL single-dose ampules (NDC 59923-719-10) Available

Dear Health Care Provider Letter

0.5% 5 mL single-dose ampules (NDC 59923-718-05) Available

Dear Health Care Provider Letter

0.5% 10 mL single-dose ampules (NDC 59923-720-10) Available

Dear Health Care Provider Letter

Baxter Healthcare (Reverified 09/28/2022)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Bupivacaine Spinal, USP (7.5 mg/mL in 8.25% dextrose) 2 mL Single Dose Ampule (10 x 2 mL)(NDC 36000-092-10) Stocked out - recovery TBD Manufacturing Delay

Eugia Pharma Specialties LTD. (formerly Aurobindo) (Reverified 09/28/2022)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.25% 10 mL Single Dose Vials (NDC 55150-167-10) Long-term backorder Shortage of active ingredient
0.25% 30 mL Single Dose Vials (NDC 55150-168-30) Long-term backorder Shortage of active ingredient
0.5% 10 mL Single Dose Vials (NDC 55150-169-10) Long-term backorder Shortage of active ingredient
0.5% 30 mL Single Dose Vials (NDC 55150-170-30) Long-term backorder Shortage of active ingredient
0.75% 10 mL Single Dose Vials (NDC 55150-171-10) Long-term backorder Shortage of active ingredient
0.75% 30 mL Single Dose Vials (NDC 55150-172-30) Long-term backorder Shortage of active ingredient
0.25% 50 mL Multiple Dose Vials (NDC 55150-249-50) Long-term backorder Shortage of active ingredient
0.5% 50 mL Multiple Dose Vials (NDC 55150-250-50) Long-term backorder Shortage of active ingredient

Fresenius Kabi USA, LLC (Revised 09/14/2022)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sensorcaine 0.25% (125 mg per 50 mL) (2.5 mg per mL) MDV (NDC 63323-465-57) Backordered. Next release October 2022. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.5% (250 mg per 50 mL) (5 mg per mL) MDV (NDC 63323-467-57) Backordered. Next release October 2022. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.25% (25 mg per 10 mL) (2.5 mg per mL) MPF, SDV (NDC 63323-464-17) Backordered. Next release October 2022. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine MPF 0.25% (75 mg per 30 mL) (2.5 mg per mL) MPF, SDV (NDC 63323-464-37) Backordered. Next release October 2022. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.25% (75 mg per 30 mL) (2.5 mg per mL) MPF, Sterile-Pak, SDV (NDC 63323-464-31) Backordered. Next release date not available at this time. Demand increase for the drug
Sensorcaine 0.5% (50 mg per 10 mL) (5 mg per mL) MPF, SDV (NDC 63323-466-17) Backordered. Next release not available at this time. Demand increase for the drug
Sensorcaine 0.5% (150 mg per 30 mL) (5 mg per mL) MPF, SDV (NDC 63323-466-37) Available Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.5% (150 mg per 30 mL) (5 mg per mL) MPF, Sterile-Pak, SDV (NDC 63323-466-31) Backordered. Next release not available at this time. Demand increase for the drug
Sensorcaine 0.75% (75 mg per 10 mL) (7.5 mg per mL) MPF, SDV (NDC 63323-472-17) Backordered. Next release not available at this time. Demand increase for the drug
Sensorcaine 0.75% (225 mg per 30 mL) (7.5 mg per mL) MPF, SDV (NDC 63323-472-37) 4 month expiry (12/2022 & 1/2023 expiry) dating available by request. Check wholesalers for inventory. Demand increase for the drug

Hospira, Inc. (Revised 09/12/2022)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
25 mg/10 mL (2.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1159-01) Next Delivery: September 2022; Estimated Recovery: December 2023

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
75 mg/30 mL (2.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1159-02) Next Delivery: September 2022; Estimated Recovery: June 2023

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
125 mg/50 mL (2.5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1160-01) Next Delivery: October 2022; Estimated Recovery: March 2023

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
50 mg/10 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1162-01) Next Delivery: November 2022; Estimated Recovery: December 2022

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
150 mg/30 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1162-02) Next Delivery: September 2022; Estimated Recovery: July 2023

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1163-01) Limited Supply Available. Next Delivery: March 2023; Estimated Recovery: July 2023

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
75 mg/10 mL (7.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1165-01) Next Delivery and Estimated Recovery: September 2022

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
225 mg/30 mL (7.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1165-02) Next Delivery: December 2022; Estimated Recovery: January 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Bupivacaine Spinal 15 mg/2 mL (7.5 mg/mL in 8.25% dextrose); Glass Ampul (NDC 00409-3613-01) Next Delivery: October 2022; Estimated Recovery: March 2023

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
Marcaine 25 mg/10 mL (2.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1559-10) Next Delivery and Estimated Recovery: February 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Marcaine 75 mg/30 mL (2.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1559-30) Next Delivery and Estimated Recovery: May 2023

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
Marcaine 125 mg/50 mL (2.5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1587-50) Next Delivery and Estimated Recovery: June 2023 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Marcaine 50 mg/10 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1560-10) Next Delivery and Estimated Recovery: December 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
Marcaine 150 mg/30 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1560-29) Next Delivery: September 2022; Estimated Recovery: March 2023

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
Marcaine 250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1610-50) Next Delivery: September 2022; Estimated Recovery: December 2022

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
Marcaine 75 mg/10 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1582-10) Next Delivery and Estimated Recovery: September 2022

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
Marcaine 225 mg/30 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1582-29) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug
Marcaine Spinal 15 mg/2 mL (7.5 mg/mL in 8.25% dextrose); Glass Ampul (NDC 00409- 1761-02) Next Delivery and Estimated Recovery: TBD

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Demand increase for the drug

Huons Co., Ltd (New 06/21/2021)

Company Contact Information:
+82-2-854-4700 or via email intbiz@huons.com

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
HCl 0.75% & Dextrose 8.25%, Injectable spinal (NDC 73293-0002) Available
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