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
Areva Pharmaceuticals, Inc. (Revised 10/19/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 0.25% 5 mL single-dose ampules (NDC 59923-717-05) | Available | ||
| 0.25% 10 mL single-dose ampules (NDC 59923-719-10) | Available | ||
| 0.5% 5 mL single-dose ampules (NDC 59923-718-05) | Available | ||
| 0.5% 10 mL single-dose ampules (NDC 59923-720-10) | Available |
Baxter Healthcare (Reverified 03/01/2023)
| 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) (Revised 03/17/2023)
| 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 | Available |
| 0.25% 30 mL Single Dose Vials (NDC 55150-168-30) | Available | Check wholesalers for inventory | Available |
| 0.5% 10 mL Single Dose Vials (NDC 55150-169-10) | Relaunch - Next shipment end of March 2023 | Intermittent availability expected | Demand increase for the drug |
| 0.5% 30 mL Single Dose Vials (NDC 55150-170-30) | Available | Available | |
| 0.75% 10 mL Single Dose Vials (NDC 55150-171-10) | Available | Check wholesalers for inventory | Available |
| 0.75% 30 mL Single Dose Vials (NDC 55150-172-30) | Available | Check wholesalers for inventory | Available |
| 0.25% 50 mL Multiple Dose Vials (NDC 55150-249-50) | Available | Check wholesalers for inventory | Available |
| 0.5% 50 mL Multiple Dose Vials (NDC 55150-250-50) | Available | Check wholesalers for inventory | Demand increase for the drug |
Fresenius Kabi USA, LLC (Revised 03/10/2023)
| 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 March 2023. | 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 March 2023. | 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) | Next release not available at this time. | 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 2023. | 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) | 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) | Backordered. Next release April 2023. | 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 March 2023. | Demand increase for the drug | |
| Sensorcaine 0.75% (225 mg per 30 mL) (7.5 mg per mL) MPF, SDV (NDC 63323-472-37) | Backordered. Next release March 2023. | Check wholesalers for inventory. | Demand increase for the drug |
Hospira, Inc., a Pfizer company (Revised 03/17/2023)
| 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: May 2023; 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: April 2023; Estimated Recovery: December 2023 | 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) | Next Delivery: April 2023; Estimated Recovery: September 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: May 2023; Estimated Recovery: September 2023 | 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) | Next Delivery: June 2023; Estimated Recovery: September 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) | Next Delivery: March 2023; Estimated Recovery: September 2023 | 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: July 2023; Estimated Recovery: March 2024 |
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: May 2023; Estimated Recovery: September 2023 |
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Demand increase for the drug |
| Bupivacaine Spinal 15 mg/2 mL (7.5 mg/mL in 8.25% dextrose); Glass Ampul (NDC 00409-3613-01) | Next Delivery: May 2023; Estimated Recovery: September 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: March 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: July 2023; Estimated Recovery: March 2024 |
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: August 2023; Estimated Recovery: September 2023 | Check Wholesaler for Availability 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: March 2023 | 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: August 2023; Estimated Recovery: December 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) | 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) | Next Delivery: March 2023; Estimated Recovery: June 2023 | 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: July 2023; Estimated Recovery: September 2023 |
Dear Customer Letter - Supply Update of Earlier Delivery Dates |
Demand increase for the drug |
Huons Co., Ltd (Revised 11/15/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| HCl 0.75% & Dextrose 8.25%, Injectable spinal (NDC 73293-0002-2) | Available |