FDA Drug Shortages
Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Ropivacaine Hydrochloride injection
Status: Currently in Shortage
»Date first posted:
03/23/2018
»Therapeutic Categories: Anesthesia
Akorn Pharmaceuticals (New 03/27/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 0.5% 5mg/mL, 30mL, 1 Vial (NDC 17478-0081-30) | Currently on allocation. Estimated full recovery by end of May 2018 | Other |
AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 06/13/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 0.2% 20 mL Single Dose Vials (NDC 55150-195-20) | Currently backordered | Next shipment early July | Demand increase for the drug |
| 0.2% 100 mL Single Dose Infusion Bottles (NDC 55150-196-99) | Currently backordered | Next shipment expected early July | Demand increase for the drug |
| 0.5% 20 mL Single Dose Vials (NDC 55150-197-20) | Limited supply available | Next shipment TBD | Demand increase for the drug |
| 0.5% 30 mL Single Dose Vials (NDC 55150-198-30) | Available, intermittent backorders expected | Next shipment TBD | Demand increase for the drug |
| 0.75% 20 mL Single Dose Vials (NDC 55150-199-20) | Currently backordered | Next shipment expected early July | Demand increase for the drug |
| 1% 10 mL Single Dose Vials (NDC 55150-200-10) | Currently backordered | Next shipment expected early July | Demand increase for the drug |
| 1% 20 mL Single Dose Vials (NDC 55150-201-20) | Currently backordered | Next shipment expected early July | Demand increase for the drug |
Fresenius Kabi USA, LLC (Revised 06/11/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 2 mg per mL / 0.2% (20 mg per 10 mL), Plastic Ampule, Sterile-Pak (NDC 63323-285-10) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 2 mg per mL / 0.2% (40 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-285-20) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 5 mg per mL / 0.5% (100 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-286-20) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 7.5 mg per mL / 0.75% (150 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-287-20) | Backordered. Next release anticipated July 2018 | Manufacturing Delay | |
| 10 mg per mL / 1% (100 mg per 10 mL), Plastic Ampule, Sterile-Pak (63323-288-10) | Backordered. Next release anticipated July 2018 | Manufacturing Delay | |
| 10 mg per mL / 1% (200 mg per 20 mL), Plastic Ampule, Sterile-Pak (NDC 63323-288-20) | Backordered. Next release anticipated July 2018 | Manufacturing Delay | |
| 2 mg per mL / 0.2% (200 mg per 100 mL), Single Dose Free Flex Bag (NDC 63323-285-61) | Backordered. Next release anticipated July 2018 | Manufacturing Delay | |
| 2 mg per mL / 0.2% (400 mg per 200 mL), Single Dose Free Flex Bag (NDC 63323-285-63) | Backordered. Next release anticipated June 2018 | Manufacturing Delay | |
| 2 mg per mL / 0.2% (200 mg per 100 mL), Single Dose Infusion Bottle (NDC 63323-285-65) | Backordered. Next release anticipated June 2018 | Check wholesaler for inventory | Manufacturing Delay |
| 2 mg per mL / 0.2% (400 mg per 200 mL), Single Dose Infusion Bottle (NDC 63323-285-64) | Backordered. Next release anticipated June 2018 | Check wholesaler for inventory | Manufacturing Delay |
| 5 mg per mL / 0.5% (500 mg per 100 mL), Single Dose Infusion Bottle (NDC 63323-286-00) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 5 mg per mL / 0.5% (1,000 mg per 200 mL), Single Dose Infusion Bottle (NDC 63323-286-63) | Backordered. Next release anticipated June 2018 | Check wholesaler for inventory | Manufacturing Delay |
| 2 mg per mL / 0.2% (20 mg per 10 mL), Single Dose Vial (NDC 63323-285-13) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 2 mg per mL / 0.2% (40 mg per 20 mL), Single Dose Vial (NDC 63323-285-23) | Backordered. Next release anticipated May 2018 | Check wholesaler for inventory | Manufacturing Delay |
| 5 mg per mL / 0.5% (150 mg per 30 mL), Single Dose Vial (NDC 63323-286-35) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 5 mg per mL / 0.5% (100 mg per 20 mL), Single Dose Vial (NDC 63323-286-23) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 7.5 mg per mL / 0.75% (150 mg per 20 mL), Single Dose Vial (NDC 63323-287-21) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 10 mg per mL / 1% (100 mg per 10 mL), Single Dose Vial (NDC 63323-288-11) | Available | Check wholesaler for inventory | Manufacturing Delay |
| 10 mg per mL / 1% (200 mg per 20 mL), Single Dose Vial (NDC 63323-288-21) | Backordered. Next release anticipated July 2018 | Manufacturing Delay | |
| 5 mg per mL / 0.5% (150 mg per 30 mL), Sterile-Pack, Single Dose Vial (NDC 63323-286-31) | Backordered. Next release anticipated August 2018 | Manufacturing Delay |
Hospira, Inc. (Reverified 06/14/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 20 mg/10 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9300-10) | Next delivery & Estimated recovery: September 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 40 mg/20 mL (2 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9300-20) | Next Delivery: June 2018; Estimated Recovery: September 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 150 mg/30 mL (5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9301-30) | Next Delivery: June 2018; Estimated Recovery: September 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 150 mg/20 mL (7.5 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9302-20) | Next delivery: July 2018 Estimated recovery: September 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 100 mg/10 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9303-10) | Next delivery & Estimated recovery: September 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 200 mg/20 mL (10 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-9303-20) | Next Delivery and Estimated Recovery: June 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
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