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 09/19/2017)
| 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 03/02/2017)
| 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) | Releasing product; however, the demand is greater than the supply at this time. | Please check with your wholesaler for available inventory. | Demand increase for the drug |
AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Reverified 03/18/2014)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1% 2 mL Ampoule (NDC 55150-158-22) | Available | All presentations are available | Demand increase for the drug |
| 1% 5 mL Ampoule (NDC 55150-159-74) | Available | All presentations are available | demand increase for the drug |
| 2% 2 mL Ampoule (NDC 55150-160-72) | Available | All presentations are available | Demand increase for the drug |
| 1% 2 mL Single Dose Vial (NDC 55150-161-02) | Available | All presentations are available | Demand increase for the drug |
| 1% 5 mL Single Dose Vial (NDC 55150-163-30) | Available | All presentations are available | Demand increase for the drug |
| 1% 30 mL Single Dose Vial (NDC 55150-163-30) | Available | All presentations are available | Demand increase for the drug |
| 2% 2 mL Single Dose Vial (NDC 55150-164-02) | Available | All presentations are available | Demand increase for the drug |
| 2% 5 mL Single Dose Vial (NDC 55150-165-05) | Available | All presentations are available | Demand increase for the drug |
Fresenius Kabi USA, LLC (Revised 09/22/2017)
| 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) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Lidocaine 2% Lidocaine 2% injection 20 mg/mL, 2 mL vial (NDC 63323-0202-02) | Available | Demand increase for the drug | |
| Lidocaine 2% injection 20 mg/mL, 5 mL SD Tear Top vial, preservative-free (NDC 63323-0208-05) | Available | 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 anticipated September 2017. | 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 anticipated September 2017. | 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 anticipated September 2017. | 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) | Available | Check wholesalers for inventory. | Demand increase for the drug |
| Xylocaine 2% - MPF injection 20 mg/mL, 5 mL vial (NDC 63323-0495-07) | Backordered. Next release date anticipated September 2017. | 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) | Available | 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) | Available | 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 2017. | 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 anticipated October 2017. | 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) | 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) | 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) | Backordered. Next release anticipated October 2017. | Check wholesalers for inventory. | Demand increase for the drug |
Hospira, Inc. (Revised 09/21/2017)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 1%; 5mL Ansyr Syringe (NDC 0409-9137-05) | Available | Shortage per manufacturer: Available | Other |
| 1.5%; 20mL Sterile Pack Amp (NDC 0409-4056-01) | Discontinued | Discontinuation of the manufacture of the drug | |
| 1%; 2 mL amp (NDC 0409-4713-32) | Available | Available | Other |
| 1%; 20 mL vial (NDC 0409-4276-01) | Available | Available | Other |
| 1%; 30 mL vial (NDC 0409-4279-02) | Available | Available | Other |
| 1%; 50 mL vial (NDC 0409-4276-02) | Next delivery & Estimated recovery: Early October 2017 | Shortage per Manufacturer: Manufacturing Delay. | Other |
| 1%; 30 mL Sterile Pack vial (NDC 0409-4270-01) | Next delivery & Estimated recovery TBD | Shortage per Manufacturer: Manufacturing Delay. | Other |
| 2%; 2 mL amp (NDC 0409-4282-01) | Available | Available | Other |
| 2%; 10 mL amp (NDC 0409-4282-02) | Next delivery: Early November 2017; Estimated recovery: November 2017 | Shortage per Manufacturer: Manufacturing Delay. | Other |
| 1%; 5 mL Abboject syringe (NDC 0409-4904-34) | Limited supply Available | Please check with your wholesaler for available inventory | Other |
| 2%; 5 mL Abboject syringe (NDC 0409-4903-34) | Next delivery: Early October 2017; Estimated recovery: December 2017 | Shortage per Manufacturer: Manufacturing Delay. | Other |
| 2%; 5 mL vial (NDC 0409-2066-05) | Next delivery: Mid October 2017; Estimated recovery: 1Q 2018 | Shortage per Manufacturer: Manufacturing Delay. | Other |
| 2%; 20 mL vial (NDC 0409-4277-01) | Available | Available | Other |
| 2%; 50 mL vial (NDC 0409-4277-02) | Available | Available | Other |
| 4%; 5 mL amp (NDC 0409-4283-01) | Next delivery: Mid September 2017; Estimated recovery: October 2017 | Shortage per Manufacturer: Manufacturing Delay. | Other |
| 0.4% in 5% Dex; 500mL flex (NDC 0409-7931-24) | Discontinued | Discontinuation of the manufacturer of the drug | |
| 0.4% in 5% Dex; 250mL flex (NDC 0409-7931-32) | Discontinued | Discontinuation of the manufacturer of the drug | |
| 0.8% in 5% Dex; 250mL flex (NDC 0409-7939-32) | Discontinued | Discontinuation of the manufacturer of the drug | |
| 2%; 5mL Ansyr syringe (NDC 0409-1323-05) | Next delivery: Early October 2017; Estimated recovery: January 2018 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 0.5%; 50 mL FT vial (NDC 0409-4275-01) | Available | Available | Other |
| 5% w/7.5% Dex; 2mL amp (NDC 0409-4712-01) | Next delivery and estimated recovery: 2Q 2018 | Shortage per Manufacturer: Manufacturing Delay | Other |
| 0.5%; 50 mL TT vial (NDC 0409-4278-01) | Available | Available | Other |
| 1%; 5 mL amp (NDC 0409-4713-02) | Next delivery: Late September 2017; Estimated recovery: 1Q 2018 | Limited Supply Available. Please check with your wholesaler for available inventory | Other |
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