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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. Discontinuation of the manufacture of the drug

Amphastar Pharmaceuticals, Inc./IMS (Reverified 08/12/2022)

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) Backordered due to the increase in demands Demand increase for the drug

Eugia Pharma Specialties LTD. (formerly Aurobindo) (Revised 09/28/2022)

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 Demand increase for the drug
1% 2 mL Ampoule (NDC 55150-158-72) Currently on backorder - next shipment anticipated Mid Oct Demand increase for the drug
1% 5 mL Ampoule (NDC 55150-159-74) Currently on backorder - next shipment TBD Demand increase for the drug
2% 2 mL Ampoule (NDC 55150-160-72) Currently on backorder - next shipment TBD Demand increase for the drug
1% 2 mL Single Dose Vial (NDC 55150-161-02) Currently on backorder - next shipment anticipated End Oct Demand increase for the drug
1% 5 mL Single Dose Vial (NDC 55150-162-05) Available Demand increase for the drug
1% 30 mL Single Dose Vial (NDC 55150-163-30) Currently on backorder - next shipment anticipated Mid Oct Demand increase for the drug
2% 2 mL Single Dose Vial (NDC 55150-164-02) Currently on backorder - next shipment TBD Demand increase for the drug
2% 5 mL Single Dose Vial (NDC 55150-165-05) Available Demand increase for the drug
1% 10 mL Multi Dose Vial (NDC 55150-251-10) Currently on backorder - next shipment TBD Demand increase for the drug
1% 20 mL Multi Dose Vial (NDC 55150-252-20) Currently on backorder - next shipment TBD Demand increase for the drug
2% 10 mL Multi Dose Vial (NDC 55150-254-10) Currently on backorder - next shipment TBD Demand increase for the drug
2% 20 mL Multi Dose Vial (NDC 55150-255-20) Currently on backorder - next shipment TBD Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 09/14/2022)

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) Backordered. Next release not available at this time. 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 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) Backordered. Next release September 2022. 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 September 2022. 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 2022. Demand increase for the drug
Xylocaine 2% injection 20 mg/mL, 20 mL vial (NDC 63323-0486-27) Backordered. Next release October 2022. Demand increase for the drug
Xylocaine 2% injection 20 mg/mL, 50 mL vial (NDC 63323-0486-57) Backordered. Next release 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) Backordered. Next release November 2022. 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. Demand increase for the drug
Xylocaine 0.5% - MPF injection, APP 5 mg/mL, 50 mL vial (NDC 63323-0491-57) Backordered. Next release not available at this time. 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 2022. 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 September 2022. Demand increase for the drug
Xylocaine 1% injection 10 mg/mL, 20 mL vial (NDC 63323-0485-27) Backordered. Next release October 2022. 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 2022. Demand increase for the drug
Xylocaine 1% - MPF injection 10 mg/mL, 2 mL vial (NDC 63323-0492-27) Backordered. Next release September 2022. 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 2022. 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 October 2022. 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 08/26/2022)

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. Demand increase for the drug
2% 5 mL vial, Preservative Free (NDC 0143-9594-25) This presentation is temporarily on backorder. Demand increase for the drug
1% 50 mL vial, Preserved (NDC 0143-9577-10) This presentation is temporarily on backorder. Demand increase for the drug
2% 50 mL vial, Preserved (NDC 0143-9575-10) This presentation is temporarily on backorder. Demand increase for the drug

Hospira, Inc. (Revised 09/30/2022)

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) Next Delivery and Estimated Recovery: September 2022 Demand increase for the drug
50 mg/5 mL (1%; 10 mg/mL); Ansyr Plastic Syringe (NDC 0409-9137-05) Next Delivery: November 2022; Estimated Recovery: December 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Pfizer Customer Letter dated August 31, 2022

Other
20 mg/2 mL (1%; 10 mg/mL); Glass Ampul (NDC 0409-4713-32) Next Delivery: September 2022; Estimated Recovery: November 2022 Demand increase for the drug
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: September 2022; Estimated Recovery: February 2023 Demand increase for the drug
300 mg/30 mL (1%; 10 mg/mL); Single Dose Glass Teartop Vial (NDC 0409-4279-02) Next Delivery: November 2022; Estimated Recovery: June 2023 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 2022; Estimated Recovery: June 2023 Demand increase for the drug
40 mg/2 mL (2%; 20 mg/mL); Glass Ampul (NDC 0409-4282-01) Next Delivery: September 2022; Estimated Recovery: October 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
200 mg/10 mL (2%; 20 mg/mL); Glass Ampul (NDC 0409-4282-02) Next Delivery: September 2022; Estimated Recovery: February 2023 Demand increase for the drug
50 mg/5 mL (1%; 10 mg/mL); LifeShield Abboject Glass Syringe (NDC 0409-4904-34) Available
100 mg/5 mL (2%; 20 mg/mL); LifeShield Abboject Glass Syringe (NDC 0409-4903-34) Limited Supply Available. Next Delivery: September 2022; Estimated Recovery: November 2022 Shortage per Manufacturer: Manufacturing Delay

Pfizer Customer Letter dated August 31, 2022

Other
100 mg/5 mL (2%; 20 mg/mL); Single Dose Glass Fliptop Vial (NDC 0409-2066-05) Next Delivery: October 2022; Estimated Recovery: March 2023 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) Limited Supply Available. Next Delivery: January 2023; Estimated Recovery: March 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay 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 and Estimated Recovery: October 2022 Demand increase for the drug
200 mg/5 mL (4%; 40 mg/mL); Glass Ampul (NDC 0409-4283-01) Next Delivery: November 2022; Estimated Recovery: January 2023 Demand increase for the drug
Xylocaine Cardiac 100 mg/5 mL (2%; 20 mg/mL); Ansyr Plastic Syringe (NDC 0409-1323-05) Next Delivery: September 2022; Estimated Recovery: December 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Pfizer Customer Letter dated August 31, 2022

Other
250 mg/50 mL (0.5%; 5 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 0409-4275-01) Next Delivery: April 2023; Estimated Recovery: June 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
250 mg/50 mL (0.5%; 5 mg/mL); Single Dose Glass Teartop Vial (NDC 0409-4278-01) Next Delivery: November 2022; Estimated Recovery: June 2023 Demand increase for the drug
50 mg/5 mL (1%; 10 mg/mL); Glass Ampul (NDC 0409-4713-02) Next Delivery: October 2022; Estimated Recovery: November 2022 Demand increase for the drug

Huons Co., Ltd. (South Korea) (New 09/06/2022)

Company Contact Information:
intbiz@huons.com

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methylparaben Free Lidocaine HCl Injection, USP 1% 50mg/5mL (Vial) (NDC 73293-0001-2) Available Demand increase for the drug

Spectra Medical Devices, Inc. (Revised 01/07/2022)

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) Available Other
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