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
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 10/07/2019)

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)	Currently backordered	Additional quantities expected in October 2019	Demand increase for the drug
0.25% 30 mL Single Dose Vials (NDC 55150-168-30)	Currently backordered	Additional quantities expected in October 2019	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)	Available	Check wholesalers for inventory	Demand increase for the drug
0.75% 10 mL Single Dose Vials (NDC 55150-171-10)	Currently backordered	Additional quantities expected in October 2019	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)	Limited supply currently available	Additional quantities expected in October 2019	Demand increase for the drug
0.5% 50 mL Multiple Dose Vials (NDC 55150-250-50)	Currently backordered	Additional quantities expected in November 2019	Demand increase for the drug

Baxter Healthcare (New 08/26/2019)

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 (Reverified 10/18/2019)

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	All Bupivacaine presentations are on intermittent back order and will be released as the product becomes available. Product will ship into the wholesalers.	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 10/07/2019)

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: December 2019; Estimated Recovery: January 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)	Limited Supply Available. Next Delivery and Estimated Recovery: October 2019	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Next Delivery: December 2019; Estimated Recovery: March 2020	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Limited Supply Available. Next Delivery: October 2019; Estimated Recovery: March 2020	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Limited Supply Available. Next Delivery: November 2019; Estimated Recovery: January 2020	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Next Delivery and Estimated Recovery: December 2019	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Next Delivery and Estimated Recovery: April 2020	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: November 2019; Estimated Recovery: April 2020	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Next Delivery: January 2020; Estimated Recovery: April 2020	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: January 2020; Estimated Recovery: April 2020	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Next Delivery: January 2020; Estimated Recovery: April 2020	Shortage per Manufacturer: Manufacturing Delay 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)	Next Delivery: December 2019; Estimated Recovery: April 2020	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Next Delivery: January 2020; Estimated Recovery: June 2020	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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)	Next Delivery: November 2019; Estimated Recovery: April 2020	Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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