FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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

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Areva Pharmaceuticals, Inc. (New 09/12/2019)

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 Areva Pharmaceuticals Inc., in conjunction with FDA, has initiated temporary importation of Bupivacaine Hydrochloride Injection USP (Preservative free, Latex free) 0.25% and 0.5% into the US market to address drug shortage. Importation will begin mid-September 2019. Product is available via authorized distributors (McKesson, Cardinal Health, Amerisource Bergen) . All orders must be placed with your authorized wholesalers. Please call Areva Pharmaceutical Customer Service at 812-399-3599, Option # 1 or email us at customerservice@arevapharma.com if you would like drop shipments.

Dear Health Care Provider Letter

0.25% 10 mL single-dose ampules (NDC 59923-719-10) Available Areva Pharmaceuticals Inc., in conjunction with FDA, has initiated temporary importation of Bupivacaine Hydrochloride Injection USP (Preservative free, Latex free) 0.25% and 0.5% into the US market to address drug shortage. Importation will begin mid-September 2019. Product is available via authorized distributors (McKesson, Cardinal Health, Amerisource Bergen) . All orders must be placed with your authorized wholesalers. Please call Areva Pharmaceutical Customer Service at 812-399-3599, Option # 1 or email us at customerservice@arevapharma.com if you would like drop shipments.

Dear Health Care Provider Letter

0.5% 5 mL single-dose ampules (NDC 59923-718-05) Available Areva Pharmaceuticals Inc., in conjunction with FDA, has initiated temporary importation of Bupivacaine Hydrochloride Injection USP (Preservative free, Latex free) 0.25% and 0.5% into the US market to address drug shortage. Importation will begin mid-September 2019. Product is available via authorized distributors (McKesson, Cardinal Health, Amerisource Bergen) . All orders must be placed with your authorized wholesalers. Please call Areva Pharmaceutical Customer Service at 812-399-3599, Option # 1 or email us at customerservice@arevapharma.com if you would like drop shipments.

Dear Health Care Provider Letter

0.5% 10 mL single-dose ampules (NDC 59923-720-10) Available Areva Pharmaceuticals Inc., in conjunction with FDA, has initiated temporary importation of Bupivacaine Hydrochloride Injection USP (Preservative free, Latex free) 0.25% and 0.5% into the US market to address drug shortage. Importation will begin mid-September 2019. Product is available via authorized distributors (McKesson, Cardinal Health, Amerisource Bergen) . All orders must be placed with your authorized wholesalers. Please call Areva Pharmaceutical Customer Service at 812-399-3599, Option # 1 or email us at customerservice@arevapharma.com if you would like drop shipments.

Dear Health Care Provider Letter

AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 12/11/2019)

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) Available Check wholesalers for inventory Demand increase for the drug
0.25% 30 mL Single Dose Vials (NDC 55150-168-30) Available Check wholesalers for inventory Demand increase for the drug
0.5% 10 mL Single Dose Vials (NDC 55150-169-10) Available Check wholesalers for inventory Demand increase for the drug
0.5% 30 mL Single Dose Vials (NDC 55150-170-30) Currently backordered Next shipment TBD Demand increase for the drug
0.75% 10 mL Single Dose Vials (NDC 55150-171-10) Available Check wholesalers for inventory Demand increase for the drug
0.75% 30 mL Single Dose Vials (NDC 55150-172-30) Available Check wholesalers for inventory Demand increase for the drug
0.25% 50 mL Multiple Dose Vials (NDC 55150-249-50) Available Check wholesaler for inventory Demand increase for the drug
0.5% 50 mL Multiple Dose Vials (NDC 55150-250-50) Available Check wholesaler for inventory Demand increase for the drug

Baxter Healthcare (Reverified 06/02/2020)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Bupivacaine HCL in 8.25% Dextrose lnjection, USP (7.5 mg/mL) 2 mL Single Dose Ampule (10 x 2 mL)(NDC 36000-092-10) Available SPINAL 0.75% - Sterile Hyperbaric Solution for Spinal Anesthesia

Fresenius Kabi USA, LLC (Revised 06/25/2020)

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) Available 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) Available 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) Available 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) Available 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. Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.5% (50 mg per 10 mL) (5 mg per mL) MPF, SDV (NDC 63323-466-17) Available Check wholesalers for inventory. 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 date 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) Available Check wholesalers for inventory. Demand increase for the drug
Sensorcaine 0.75% (225 mg per 30 mL) (7.5 mg per mL) MPF, SDV (NDC 63323-472-37) Available Check wholesalers for inventory. Demand increase for the drug

Hospira, Inc. (Revised 07/01/2020)

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) Limited Supply Available. Next Delivery: July 2020; Estimated Recovery: September 2020 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
75 mg/30 mL (2.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1159-02) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
125 mg/50 mL (2.5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1160-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
50 mg/10 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1162-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
150 mg/30 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1162-02) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1163-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
75 mg/10 mL (7.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1165-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
225 mg/30 mL (7.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1165-02) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Bupivacaine Spinal 15 mg/2 mL (7.5 mg/mL); Glass Ampul (NDC 00409-3613-01) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Marcaine 25 mg/10 mL (2.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1559-10) Available

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) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Marcaine 125 mg/50 mL (2.5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1587-50) Available

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) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Marcaine 150 mg/30 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1560-29) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Marcaine 250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1610-50) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
Marcaine 75 mg/10 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1582-10) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other
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

Other
Marcaine Spinal 15 mg/2 mL (7.5 mg/mL); Glass Ampul (NDC 00409- 1761-02) Available

Dear Customer Letter - Supply Update of Earlier Delivery Dates

Other

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