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

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American Regent/Luitpold (Reverified 03/30/2021)

Company Contact Information:
800-645-1706

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 09/03/2021)

Company Contact Information:
800-423-4136

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 10/22/2021)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2% MDV 1000mg/50mL (NDC 55150-256-50) Currently on backorder - next shipment TBD Sporadic availability expected. 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 Sporadic availability expected. 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) Currently on backorder - next shipment anticipated early Nov Sporadic availability expected. Demand increase for the drug
1% 5 mL Single Dose Vial (NDC 55150-162-05) Currently on backorder - next shipment anticipated in November Sporadic availability expected. Demand increase for the drug
1% 30 mL Single Dose Vial (NDC 55150-163-30) Currently on backorder - next shipment anticipated mid November Sporadic availability expected. Demand increase for the drug
2% 2 mL Single Dose Vial (NDC 55150-164-02) Currently on backorder - next shipment TBD Sporadic availability expected. Demand increase for the drug
2% 5 mL Single Dose Vial (NDC 55150-165-05) Available Sporadic availability expected. 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 TBD Sporadic availability expected. Demand increase for the drug
2% 10 mL Multi Dose Vial (NDC 55150-254-10) Currently on backorder - next shipment anticipated in November 2021. Sporadic availability expected. Demand increase for the drug
2% 20 mL Multi Dose Vial (NDC 55150-255-20) Currently on backorder - next shipment TBD Check wholesalers for inventory Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 10/25/2021)

Company Contact Information:
888-386-1300

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) 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 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) Available Check wholesalers for inventory. Demand increase for the drug
Xylocaine 2% injection 20 mg/mL, 10 mL vial (NDC 63323-0486-17) Available 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) Backordred. Next release date not available at this time. 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) Backordered. Next release not available at this time. 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 date not available at this time. 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) Backordered. Next release December 2021. 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 November 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 November 2021. 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) Backordered. Next release November 2021. 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 10/12/2021)

Company Contact Information:
800-631-2174

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 will be scheduled for manufacturing in the October - November 2021 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) Inventory is currently available. Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. Demand increase for the drug
1% 50 mL vial, Preserved (NDC 0143-9577-10) Inventory is currently available. Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. Demand increase for the drug
2% 50 mL vial, Preserved (NDC 0143-9575-10) Inventory is currently available. Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released. Demand increase for the drug

Hospira, Inc. (Revised 10/21/2021)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
300 mg/20 mL (1.5%; 15 mg/mL); Glass Ampul (NDC 0409-4776-01) Available Other
50 mg/5 mL (1%; 10 mg/mL); Ansyr Plastic Syringe (NDC 0409-9137-05) Available Other
20 mg/2 mL (1%; 10 mg/mL); Glass Ampul (NDC 0409-4713-32) Available
200 mg/20 mL (1%; 10 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4276-01, pack of 25; NDC 0409-4276-16, individual) Next Delivery: October 2021; Estimated Recovery: August 2022 Demand increase for the drug
300 mg/30 mL (1%; 10 mg/mL); Single Dose Glass Teartop Vial (NDC 0409-4279-02) Next Delivery: March 2022; Estimated Recovery: September 2022 Demand increase for the drug
500 mg/50 mL (1%; 10 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4276-02; NDC 0409-4276-17, individual) Next Delivery: October 2021; Estimated Recovery: November 2021 Demand increase for the drug
40 mg/2 mL (2%; 20 mg/mL); Glass Ampul (NDC 0409-4282-01) Next Delivery and Estimated Recovery: November 2021 Demand increase for the drug
200 mg/10 mL (2%; 20 mg/mL); Glass Ampul (NDC 0409-4282-02) Limited Supply Available. Next Delivery: November 2021; Estimated Recovery: December 2021 Demand increase for the drug
50 mg/5 mL (1%; 10 mg/mL); LifeShield Abboject Glass Syringe (NDC 0409-4904-34) Available Other
100 mg/5 mL (2%; 20 mg/mL); LifeShield Abboject Glass Syringe (NDC 0409-4903-34) Limited Supply Available. Next Delivery: November 2021; Estimated Recovery: December 2021 Shortage per Manufacturer: Manufacturing Delay Other
100 mg/5 mL (2%; 20 mg/mL); Single Dose Glass Fliptop Vial (NDC 0409-2066-05) Next Delivery: November 2021; Estimated Recovery: May 2022 Demand increase for the drug
400 mg/20 mL (2%; 20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4277-01, pack of 25; NDC 0409-4277-16, individual) Next Delivery: January 2022; Estimated Recovery: January 2023 Demand increase for the drug
1,000 mg/50 mL (2%; 20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4277-02) Next Delivery: October 2021; Estimated Recovery: April 2022 Demand increase for the drug
200 mg/5 mL (4%; 40 mg/mL); Glass Ampul (NDC 0409-4283-01) Next Delivery and Estimated Recovery: November 2021 Demand increase for the drug
Xylocaine Cardiac 100 mg/5 mL (2%; 20 mg/mL); Ansyr Plastic Syringe (NDC 0409-1323-05) Next Delivery: December 2021; Estimated Recovery: January 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
250 mg/50 mL (0.5%; 5 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4275-01) Unavailable. Next Delivery and Estimated Recovery: January 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
100 mg/2 mL (5%; 50 mg/mL) and 7.5% Dextrose; Glass Ampul (NDC 0409-4712-01) Unavailable. Next Delivery: September 2022; Estimated Recovery: December 2022 Shortage per Manufacturer: Manufacturing Delay Other
250 mg/50 mL (0.5%; 5 mg/mL); Single Dose Glass Teartop Vial (NDC 0409-4278-01) Limited Supply Available. Next Delivery and Estimated Recovery: December 2021 Demand increase for the drug
50 mg/5 mL (1%; 10 mg/mL); Glass Ampul (NDC 0409-4713-02) Available Other

Spectra Medical Devices, Inc. (New 06/14/2018)

Company Contact Information:
978-657-0889 ext. 5231

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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