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 10/02/2018)
| 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 |
| 2%, 50 mL vial package of 25 (NDC 00517-0626-25) | 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 (Revised 08/20/2018)
| 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 08/03/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1% 2 mL Ampoule (NDC 55150-158-72) | Currently backordered | Additional quantities expected by early October | Demand increase for the drug |
| 1% 5 mL Ampoule (NDC 55150-159-74) | Currently backordered | Additional quantities expected by early September | Demand increase for the drug |
| 2% 2 mL Ampoule (NDC 55150-160-72) | Currently backordered | Additional quantities expected by early October | Demand increase for the drug |
| 1% 2 mL Single Dose Vial (NDC 55150-161-02) | Currently backordered | Additional quantities expected by early September | Demand increase for the drug |
| 1% 5 mL Single Dose Vial (NDC 55150-163-30) | Currently backordered | Additional quantities expected by late September | Demand increase for the drug |
| 1% 30 mL Single Dose Vial (NDC 55150-163-30) | Currently backordered | Additional quantities expected by late September | Demand increase for the drug |
| 2% 2 mL Single Dose Vial (NDC 55150-164-02) | Currently in stock | Intermittent backorders expected | Demand increase for the drug |
| 2% 5 mL Single Dose Vial (NDC 55150-165-05) | Currently backordered | Next shipment TBD | Demand increase for the drug |
| 1% 10 mL Multi Dose Vial (NDC 55150-252-10) | Currently backordered | Next shipment TBD | Demand increase for the drug |
| 1% 20 mL Multi Dose Vial (NDC 55150-252-20) | Currently backordered | Additional quantities expected by early October | Demand increase for the drug |
| 2% 10 mL Multi Dose Vial (NDC 55150-254-10) | Currently backordered | Additional quantities expected by early November | Demand increase for the drug |
| 2% 20 mL Multi Dose Vial (NDC 55150-255-20) | Currently backordered | Additional quantities expected by late October | Demand increase for the drug |
Fresenius Kabi USA, LLC (Revised 10/15/2018)
| 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 | All lidocaine and Xylocaine presentations are on intermittent back order and will be released as the product becomes available. Shortage per Manufacturer: Increase in demand | 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 December 2018. | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 2% Lidocaine 2% injection 20 mg/mL, 2 mL vial (NDC 63323-0202-02) | Backordered. Next release November 2018. | 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 November 2018. | 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 October 2018. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% injection 20 mg/mL, 20 mL vial (NDC 63323-0486-27) | Backordered. Next release November 2018. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% injection 20 mg/mL, 50 mL vial (NDC 63323-0486-57) | Backordered. Next release October 2018. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% injection 20 mg/mL, 10 mL vial (NDC 63323-0486-10) discontinued | No release date available at this time. | All lidocaine and Xylocaine presentations are on intermittent back order and will be released as the product becomes available. Shortage per Manufacturer: Increase in demand | Demand increase for the drug |
| Xylocaine 2% injection NDC discontinued 20 mg/mL, 20 mL vial (NDC 63323-0486-20)-NDC discontinued | No release date available at this time. | All lidocaine and Xylocaine presentations are on intermittent back order and will be released as the product becomes available. Shortage per Manufacturer: Increase in demand | Demand increase for the drug |
| Xylocaine 2% injection 20 mg/mL, 50 mL vial (NDC 63323-0486-50)-NDC discontinued | No release date available at this time. | All lidocaine and Xylocaine presentations are on intermittent back order and will be released as the product becomes available. Shortage per Manufacturer: Increase in demand | Demand increase for the drug |
| Xylocaine 2% - MPF injection 20 mg/mL, 2 mL vial (NDC 63323-0495-27) | Backordered. Next release October 2018. | 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) | Backordered. Next release anticipated December 2018. | 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) | Backordered. Next release date 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) | Backordered. Next release anticipated October 2018. | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 1% Lidocaine 1% injection 10 mg/mL, 2 mL vial (NDC 63323-0201-02) | Backordered. Next release October 2018. | 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 December 2018. | 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 anticipated October 2018. | 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 October 2018. | Demand increase for the drug | |
| Xylocaine 1% - MPF injection 10 mg/mL, 2 mL vial (NDC 63323-0492-27) | Backordered. Next release October 2018. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 1% - MPF injection 10 mg/mL, 2 mL glass ampule (NDC 63323-0492-80) | Backordered. No release expectations at this time. | Demand increase for the drug | |
| Xylocaine 1% - MPF injection 10 mg/mL, 5 mL glass ampule (NDC 63323-0492-89) | Backordered. No release expectations at this time. | Demand increase for the drug | |
| Xylocaine 1% - MPF injection 10 mg/mL, 5 mL vial (NDC 63323-0492-57) | Backordered. Next release October 2018. | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 1% - MPF injection 10 mg/mL, 30 mL vial (NDC 63323-0492-37) | Backordered. Next release December 2018. | 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) | Backordered. Next release date not available at this time. | Demand increase for the drug |
Hospira, Inc. (Revised 10/11/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 50 mg/5 mL (10 mg/mL); Ansyr Plastic Syringe (NDC 00409-9137-05) | Next Delivery: November 2018; Estimated Recovery: December 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 1.5%; 20mL Sterile Pack Amp (NDC 00409-4056-01) | Discontinued | Discontinuation of the manufacture of the drug | |
| 20 mg/2 mL (10 mg/mL); Glass Ampul (NDC 00409-4713-32) | Next Delivery and Estimated Recovery: November 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 200 mg/20 mL (10 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4276-01) | Next Delivery: October 2018; Estimated Recovery: June 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 300 mg/30 mL (10 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-4279-02) | Next Delivery: October 2018; Estimated Recovery: December 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 500 mg/50 mL (10 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4276-02) | Next Delivery: October 2018; Estimated Recovery: March 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 1%; 30 mL Sterile Pack vial (NDC 00409-4270-01) | Discontinued | Discontinuation of the manufacture of the drug | |
| 40 mg/2 mL (20 mg/mL); Glass Ampul (NDC 00409-4282-01) | Available | Other | |
| 200 mg/10 mL (20 mg/mL); Glass Ampul (NDC 00409-4282-02) | Next Delivery: October 2018; Estimated Recovery: June 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 50 mg/5 mL (10 mg/mL); LifeShield Abboject Glass Syringe (NDC 00409-4904-34) | Next Delivery and Estimated Recovery: December 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 100 mg/5 mL (20 mg/mL); LifeShield Abboject Glass Syringe (NDC 00409-4903-34) | Next Delivery and Estimated Recovery: December 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 100 mg/5 mL (20 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2066-05) | Next Delivery: September 2019; Estimated Recovery: December 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 400 mg/20 mL (20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4277-01) | Next Delivery: October 2018; Estimated Recovery: June 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 1,000 mg/50 mL (20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4277-02) | Next Delivery: October 2018; Estimated Recovery: December 2018 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 200 mg/5 mL (40 mg/mL); Glass Ampul (NDC 00409-4283-01) | Next Delivery: December 2018; Estimated Recovery: June 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| Xylocaine Cardiac 100 mg/5 mL (20 mg/mL); Ansyr Plastic Syringe (NDC 00409-1323-05) | Next Delivery: October 2018; Estimated Recovery: March 2019 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 250 mg/50 mL (5 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4275-01) | Next Delivery and Estimated Recovery: March 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 100 mg/2 mL (50 mg/mL); Glass Ampul (NDC 00409-4712-01) | Next Delivery: 2019 and Estimated Recovery: September 2019 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 250 mg/50 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-4278-01) | Next Delivery: December 2018; Estimated Recovery: March 2019 | Check Wholesaler for Availability. Shortage per Manufacturer: Manufacturing Delay | Other |
| 50 mg/5 mL (10 mg/mL); Glass Ampul (NDC 00409-4713-02) | Next Delivery: March 2020; Estimated Recovery: 2020 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 300 mg/20 mL (15 mg/mL); Glass Ampul (NDC 0409-4776-01) | Next Delivery: March 2019; Estimated Recovery: September 2019 | 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 |
West-Ward Pharmaceuticals (Reverified 10/03/2018)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1% 5 mL vial, Preservative Free (NDC 0143-9595-25) | This presentation is temporarily on backorder. | Additional lots are scheduled to be manufactured and available in the October 2018 timeframe. Product will be made available as it is released. | Demand increase for the drug |
| 2% 5 mL vial, Preservative Free (NDC 0143-9594-25) | This presentation is temporarily on backorder. | Additional lots are scheduled to be manufactured and available in the October 2018 timeframe. 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 are scheduled to be manufactured and available in the October 2018 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 are scheduled to be manufactured and available in the October 2018 timeframe. Product will be made available as it is released. | Demand increase for the drug |
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