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:
No date available
»Therapeutic Categories: Anesthesia
AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 06/07/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 0.25% 10 mL Single Dose Vials (NDC 55150-167-10) | Limited supply, intermittent backorders expected | Additional quantities expected by late July | Demand increase for the drug |
| 0.25% 30 mL Single Dose Vials (NDC 55150-168-30) | Limited supply, intermittent backorders expected | Additional quantities expected by late August | Demand increase for the drug |
| 0.5% 10 mL Single Dose Vials (NDC 55150-169-10) | Limited supply, intermittent backorders expected | Additional quantities expected by mid-June | Demand increase for the drug |
| 0.5% 30 mL Single Dose Vials (NDC 55150-170-30) | Limited supply, intermittent backorders expected | Additional quantities expected by mid-June | Demand increase for the drug |
| 0.75% 10 mL Single Dose Vials (NDC 55150-171-10) | Currently available, intermittent backorders expected | Next shipment TBD | Demand increase for the drug |
| 0.75% 30 mL Single Dose Vials (NDC 55150-172-30) | Limited supply, intermittent backorders expected | Additional quantities expected by early September | Demand increase for the drug |
| 0.25% 50 mL Multiple Dose Vials (NDC 55150-249-50) | Currently backordered | Additional quantities expected by mid-June | Demand increase for the drug |
| 0.5% 50 mL Multiple Dose Vials (NDC 55150-250-50) | Currently backordered | Additional quantities expected by early September | Demand increase for the drug |
Fresenius Kabi USA, LLC (Revised 06/26/2018)
| 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 anticipated July 2018. | 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) | Backordered. Next release anticipated July 2018. | 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 anticipated July 2018. | 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 anticipated July 2018. | 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) | Backordered. Next release anticipated July 2018. | 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 anticipated July 2018. | 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) | Backordered. Next release date 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) | Backordered. Next release date not available at this time. | Check wholesalers for inventory. | Demand increase for the drug |
Hospira, Inc. (Revised 07/20/2018)
| 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 2018; Estimated Recovery: 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 75 mg/30 mL (2.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1159-02) | Next Delivery: November 2018; Estimated Recovery: 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 125 mg/50 mL (2.5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1160-01) | Next Delivery: July 2018; Estimated Recovery: September 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 50 mg/10 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1162-01) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 150 mg/30 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1162-02) | Next Delivery: August 2018; Estimated Recovery: 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1163-01) | Next Delivery: August 2018; Estimated Recovery: December 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 75 mg/10 mL (7.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1165-01) | Next Delivery: September 2018; Estimated Recovery: December 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 225 mg/30 mL (7.5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-1165-02) | Next Delivery: November 2018; Estimated Recovery: December 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| Bupivacaine Spinal 15 mg/2 mL (7.5 mg/mL); Glass Ampul (NDC 00409-3613-01) | Next Delivery: September 2018; Estimated Recovery: October 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine 25 mg/10 mL (2.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1559-10) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine 75 mg/30 mL (2.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1559-30) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine 125 mg/50 mL (2.5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1587-50) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine 50 mg/10 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1560-10) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine 150 mg/30 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1560-29) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine 250 mg/50 mL (5 mg/mL); Multiple Dose Glass Fliptop Vial (NDC 00409-1610-50) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine 75 mg/10 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1582-10) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine 225 mg/30 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-1582-29) | Next Delivery and Estimated Recovery: 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| Marcaine Spinal 15 mg/2 mL (7.5 mg/mL); Glass Ampul (NDC 00409- 1761-02) | Next Delivery: August 2018; Estimated Recovery: September 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
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