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 09/03/2021)

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) 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) Currently on backorder - next shipment anticipated late Sept 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) Available Check wholesalers for inventory Demand increase for the drug
1% 5 mL Single Dose Vial (NDC 55150-162-05) Currently on backorder - next shipment anticipated first week of Sept Sporadic availability expected. Demand increase for the drug
1% 30 mL Single Dose Vial (NDC 55150-163-30) Currently on backorder - next shipment anticipated end of Sept Sporadic availability expected. 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) Currently on backorder - next shipment anticipated first week of Sept 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) Available Check wholesalers for inventory Demand increase for the drug
2% 10 mL Multi Dose Vial (NDC 55150-254-10) Currently on backorder - next shipment TBD Sporadic availability expected. Demand increase for the drug
2% 20 mL Multi Dose Vial (NDC 55150-255-20) Available Check wholesalers for inventory Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 08/25/2021)

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) 5 month expiry (1/2022 expiry) dating available by request. Next release date not available at this time. 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 September 2021. 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) Backordered. Next release September 2021. 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 September 2021. 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 October 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 September 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 September 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) 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 07/06/2021)

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) Inventory is currently available. Additional lots will be scheduled for manufacturing in the July - August 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) This presentation is temporarily on backorder. Additional lots will be scheduled for manufacturing in the July - August 2021 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 will be scheduled for manufacturing in the July - August 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 July - August 2021 timeframe. Product will be made available as it is released. Demand increase for the drug

Hospira, Inc. (Revised 09/09/2021)

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 Demand increase for the drug
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: September 2021; Estimated Recovery: January 2022 Demand increase for the drug
300 mg/30 mL (1%; 10 mg/mL); Single Dose Glass Teartop Vial (NDC 0409-4279-02) Limited Supply Available. Next Delivery: September 2021; Estimated Recovery: October 2021 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: September 2021; Estimated Recovery: March 2022 Demand increase for the drug
40 mg/2 mL (2%; 20 mg/mL); Glass Ampul (NDC 0409-4282-01) Limited Supply Available. 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) Available Other
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) Next Delivery: September 2021; Estimated Recovery: October 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: September 2021; Estimated Recovery: March 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: September 2021; Estimated Recovery: March 2022 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: September 2021; Estimated Recovery: January 2022 Demand increase for the drug
200 mg/5 mL (4%; 40 mg/mL); Glass Ampul (NDC 0409-4283-01) Limited Supply Available. Next Delivery and Estimated Recovery: October 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: September 2021; Estimated Recovery: December 2021 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) Available
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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