FDA Drug Shortages
Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Lidocaine Hydrochloride (Xylocaine) Injection
Status: Currently in Shortage
»Date first posted:
02/22/2012
»Therapeutic Categories: Anesthesia; Pediatric
American Regent/Luitpold (Reverified 07/08/2020)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1%, 50 mL vial package of 25 (NDC 00517-0625-25) | Unavailable-No product available for release. No plan to manufacture. | American Regent/Luitpold has discontinued manufacturing Lidocaine HCl Injection, USP | Discontinuation of the manufacture of the drug |
Amphastar Pharmaceuticals, Inc./IMS (Reverified 02/03/2021)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 2%, 5mL Luer-Jet Prefilled Syringe (NDC 76329-3390-1) (old NDC 0548-3390-00) | Available | Demand increase for the drug |
AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 02/19/2021)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 2% MDV 1000mg/50mL (NDC 55150-025-650) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 1% 2 mL Ampoule (NDC 55150-158-72) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 1% 5 mL Ampoule (NDC 55150-159-74) | Available | Next shipment expected Jan. 2020 | Demand increase for the drug |
| 2% 2 mL Ampoule (NDC 55150-160-72) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 1% 2 mL Single Dose Vial (NDC 55150-161-02) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 1% 5 mL Single Dose Vial (NDC 55150-162-05) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 1% 30 mL Single Dose Vial (NDC 55150-163-30) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 2% 2 mL Single Dose Vial (NDC 55150-164-02) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 2% 5 mL Single Dose Vial (NDC 55150-165-05) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 1% 10 mL Multi Dose Vial (NDC 55150-251-10) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 1% 20 mL Multi Dose Vial (NDC 55150-252-20) | Currently on backorder - next shipment anticipated end of April 21 | Sporadic availability expected. | Demand increase for the drug |
| 2% 10 mL Multi Dose Vial (NDC 55150-254-10) | Available | Check wholesalers for inventory | Demand increase for the drug |
| 2% 20 mL Multi Dose Vial (NDC 55150-255-20) | Currently on backorder - next shipment anticipated end of April 21 | Sporadic availability expected. | Demand increase for the drug |
Fresenius Kabi USA, LLC (Revised 02/16/2021)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Lidocaine 1.5% Xylocaine 1.5% - MPF injection 15 mg/mL, 10 mL ampule (NDC 63323-0493-97) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 1.5% Xylocaine 1.5% - MPF injection 15 mg/mL, 20 mL ampule (NDC 63323-0493-91) | Backordered. Next release date not available at this time. | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 2% Lidocaine 2% injection 20 mg/mL, 2 mL vial (NDC 63323-0202-02) | Backordred. Next release date not available at this time. | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 2% injection 20 mg/mL, 5 mL SD Tear Top vial, preservative-free (NDC 63323-0208-05) | Backordered. Next release February 2021. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% injection 20 mg/mL, 10 mL vial (NDC 63323-0486-17) | Backordered. Next release March 2021. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% injection 20 mg/mL, 20 mL vial (NDC 63323-0486-27) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% injection 20 mg/mL, 50 mL vial (NDC 63323-0486-57) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% injection 20 mg/mL, 10 mL vial (NDC 63323-0486-10) discontinued | Not available at this time. | Demand increase for the drug | |
| Xylocaine 2% injection NDC discontinued 20 mg/mL, 20 mL vial (NDC 63323-0486-20)-NDC discontinued | Not available at this time. | Demand increase for the drug | |
| Xylocaine 2% injection 20 mg/mL, 50 mL vial (NDC 63323-0486-50)-NDC discontinued | Not available at this time. | Demand increase for the drug | |
| Xylocaine 2% - MPF injection 20 mg/mL, 2 mL vial (NDC 63323-0495-27) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% - MPF injection 20 mg/mL, 5 mL vial (NDC 63323-0495-07) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% - MPF injection 20 mg/mL, 10 mL ampule (NDC 63323-0496-97) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 0.5% Xylocaine 0.5% injection 5 mg/mL, 50 mL vial (NDC 63323-0484-57) | Not available at this time. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 0.5% - MPF injection, APP 5 mg/mL, 50 mL vial (NDC 63323-0491-57) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 1% Lidocaine 1% injection 10 mg/mL, 2 mL vial (NDC 63323-0201-02) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 1% Lidocaine 1% injection 10 mg/mL, 10 mL vial (NDC 63323-0201-10) | Backordered. Next release March 2021. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 1% injection 10 mg/mL, 20 mL vial (NDC 63323-0485-27) | Backordered. Next release March 2021. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 1% injection 10 mg/mL, 50 mL vial (NDC 63323-0485-57) | Backordered. Next release December 2019. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 1% - MPF injection 10 mg/mL, 2 mL vial (NDC 63323-0492-27) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 1% - MPF injection 10 mg/mL, 2 mL glass ampule (NDC 63323-0492-80) | Not available at this time. | Demand increase for the drug | |
| Xylocaine 1% - MPF injection 10 mg/mL, 5 mL glass ampule (NDC 63323-0492-89) | Not available at this time. | Demand increase for the drug | |
| Xylocaine 1% - MPF injection 10 mg/mL, 5 mL vial (NDC 63323-0492-57) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 1% - MPF injection 10 mg/mL, 30 mL vial (NDC 63323-0492-37) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 1% - MPF injection 10 mg/mL, 30 mL vial, sterile pack (NDC 63323-0492-31) | Not available at this time. | Demand increase for the drug |
Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 02/05/2021)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1% 5 mL vial, Preservative Free (NDC 0143-9595-25) | Inventory is currently available. | Additional lots will be scheduled for manufacturing. Product will be made available as it is released. | Demand increase for the drug |
| 2% 5 mL vial, Preservative Free (NDC 0143-9594-25) | Inventory is currently available. | Additional lots are scheduled to be manufactured. Product will be made available as it is released. | Demand increase for the drug |
| 1% 50 mL vial, Preserved (NDC 0143-9577-10) | This presentation is temporarily on backorder. | Additional lots will be scheduled for manufacturing in the February - March 2021 timeframe. Product will be made available as it is released. | Demand increase for the drug |
| 2% 50 mL vial, Preserved (NDC 0143-9575-10) | This presentation is temporarily on backorder. | Additional lots will be scheduled for manufacturing in the February - March 2021 timeframe. Product will be made available as it is released. | Demand increase for the drug |
Hospira, Inc. (Revised 02/23/2021)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 300 mg/20 mL (15 mg/mL); Glass Ampul (NDC 0409-4776-01) | Available | Other | |
| 50 mg/5 mL (10 mg/mL); Ansyr Plastic Syringe (NDC 0409-9137-05) | Limited Supply Available. Next Delivery: June 2021; Estimated Recovery: August 2021 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 1.5%; 20mL Sterile Pack Amp (NDC 0409-4056-01) | Discontinued | Discontinuation of the manufacture of the drug | |
| 20 mg/2 mL (10 mg/mL); Glass Ampul (NDC 0409-4713-32) | Available | Other | |
| 200 mg/20 mL (10 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4276-01, pack of 25; NDC 0409-4276-16, individual) | Available | Other | |
| 300 mg/30 mL (10 mg/mL); Single Dose Glass Teartop Vial (NDC 0409-4279-02) | Available |
Extended Use Dates Provided by Pfizer to Assist with Lidocaine Injection Shortages |
Other |
| 500 mg/50 mL (10 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4276-02) | Next Delivery: February 2021; Estimated Recovery: April 2021 | Demand increase for the drug | |
| 1%; 30 mL Sterile Pack vial (NDC 0409-4270-01) | Discontinued | Discontinuation of the manufacture of the drug | |
| 40 mg/2 mL (20 mg/mL); Glass Ampul (NDC 0409-4282-01) | Limited Supply Available. Next Delivery and Estimated Recovery: April 2021 | Demand increase for the drug | |
| 200 mg/10 mL (20 mg/mL); Glass Ampul (NDC 0409-4282-02) | Available | Other | |
| 50 mg/5 mL (10 mg/mL); LifeShield Abboject Glass Syringe (NDC 0409-4904-34) | Available | Other | |
| 100 mg/5 mL (20 mg/mL); LifeShield Abboject Glass Syringe (NDC 0409-4903-34) | Next Delivery: April 2021; Estimated Recovery: June 2021 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 100 mg/5 mL (20 mg/mL); Single Dose Glass Fliptop Vial (NDC 0409-2066-05) | Available | Other | |
| 400 mg/20 mL (20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4277-01, pack of 25; NDC 0409-4277-16, individual) | Available | Other | |
| 1,000 mg/50 mL (20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4277-02) | Available | Other | |
| 200 mg/5 mL (40 mg/mL); Glass Ampul (NDC 0409-4283-01) | Available | Other | |
| Xylocaine Cardiac 100 mg/5 mL (20 mg/mL); Ansyr Plastic Syringe (NDC 0409-1323-05) | Limited Supply Available. Next Delivery: February 2021; Estimated Recovery: July 2021 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 250 mg/50 mL (5 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4275-01) | Next Delivery and Estimated Recovery: January 2022 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 100 mg/2 mL (50 mg/mL); Glass Ampul (NDC 0409-4712-01) | Next Delivery: September 2022; Estimated Recovery: December 2022 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 250 mg/50 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 0409-4278-01) | Available | Other | |
| 50 mg/5 mL (10 mg/mL); Glass Ampul (NDC 0409-4713-02) | Next Delivery and Estimated Recovery: March 2021 | Shortage per Manufacturer: Manufacturing Delay | Other |
Spectra Medical Devices, Inc. (New 06/14/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1% 5 mL ampule (NDC 65282-1605-1) | Currently available, in stock Production is ongoing | Other |
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