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
Areva Pharmaceuticals, Inc. (New 09/12/2019)
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. | |
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. | |
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. | |
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. |
AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 02/19/2021)
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) | Available | Check wholesalers for inventory | 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) | Currently on backorder - next shipment anticipated Apr 21 | Sporadic availability expected. | Demand increase for the drug |
Baxter Healthcare (Reverified 01/27/2021)
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 | SPINAL 0.75% - Sterile Hyperbaric Solution for Spinal Anesthesia | Manufacturing Delay |
Fresenius Kabi USA, LLC (Revised 02/16/2021)
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) | Backordered. Next release March 2021. | 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 02/23/2021)
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 and Estimated Recovery: March 2021 |
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: March 2021; Estimated Recovery: June 2021 |
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) | 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) | Limited Supply Available. Next Delivery: April 2021; Estimated Recovery: June 2021 |
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) | 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 in 8.25% dextrose); 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 in 8.25% dextrose); Glass Ampul (NDC 00409- 1761-02) | Available |
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Other |
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