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 03/19/2019)

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
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)

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 03/05/2019)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1% 2 mL Ampoule (NDC 55150-158-72) Available Available Demand increase for the drug
1% 5 mL Ampoule (NDC 55150-159-74) Available Available Demand increase for the drug
2% 2 mL Ampoule (NDC 55150-160-72) Available Available Demand increase for the drug
1% 2 mL Single Dose Vial (NDC 55150-161-02) Available Available Demand increase for the drug
1% 5 mL Single Dose Vial (NDC 55150-163-30) Available Available Demand increase for the drug
1% 30 mL Single Dose Vial (NDC 55150-163-30) Available Available Demand increase for the drug
2% 2 mL Single Dose Vial (NDC 55150-164-02) Available Available Demand increase for the drug
2% 5 mL Single Dose Vial (NDC 55150-165-05) Currently backordered Additional quantities expected by early April 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 late March Demand increase for the drug
2% 10 mL Multi Dose Vial (NDC 55150-254-10) Available Available Demand increase for the drug
2% 20 mL Multi Dose Vial (NDC 55150-255-20) Currently backordered Additional quantities expected by early April Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 03/04/2019)

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 date not 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
Lidocaine 1.5% Xylocaine 1.5% - MPF injection 15 mg/mL, 20 mL ampule (NDC 63323-0493-91) Backordered. Next release March 2019. 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) Backordered. Next release March 2019. Check wholesalers for inventory. Demand increase for the drug
Xylocaine 2% injection 20 mg/mL, 50 mL vial (NDC 63323-0486-57) Available 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. 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. 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. 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 March 2019. 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) 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) 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 not available at this time. 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 March 2019. 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 March 2019. Check wholesalers for inventory. Demand increase for the drug
Xylocaine 1% injection 10 mg/mL, 50 mL vial (NDC 63323-0485-57) Available Check wholesalers for inventory. Demand increase for the drug
Xylocaine 1% - MPF injection 10 mg/mL, 2 mL vial (NDC 63323-0492-27) Backordered. Next release March 2019. 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) Backordered. Next release April 2019. 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

Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 03/20/2019)

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) Available Demand increase for the drug
2% 5 mL vial, Preservative Free (NDC 0143-9594-25) Available Demand increase for the drug
1% 50 mL vial, Preserved (NDC 0143-9577-10) Available Demand increase for the drug
2% 50 mL vial, Preserved (NDC 0143-9575-10) Available Demand increase for the drug

Hospira, Inc. (Revised 02/28/2019)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
300 mg/20 mL (15 mg/mL); Glass Ampul (NDC 0409-4776-01) Next Delivery and Estimated Recovery: December 2019 Shortage per Manufacturer: Manufacturing Delay Other
50 mg/5 mL (10 mg/mL); Ansyr Plastic Syringe (NDC 00409-9137-05) Next Delivery: February 2019; Estimated Recovery: March 2021 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) Limited Supply Available. Next Delivery and Estimated Recovery: February 2019 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: March 2019; Estimated Recovery: June 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Extended Use Dates Provided by Pfizer to Assist with Shortages

Other
300 mg/30 mL (10 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-4279-02) Limited Supply Available. Next Delivery: March 2019; Estimated Recovery: September 2019 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) Limited Supply Available. Next Delivery: March 2019; Estimated Recovery: July 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: June 2019; Estimated Recovery: July 2019 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: August 2019 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: March 2019; Estimated Recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
100 mg/5 mL (20 mg/mL); Single Dose Glass Fliptop Vial (NDC 00409-2066-05) Next Delivery and Estimated Recovery: December 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
400 mg/20 mL (20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4277-01) Next Delivery: June 2019; Estimated Recovery: September 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Extended Use Dates Provided by Pfizer to Assist with Shortages

Other
1,000 mg/50 mL (20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4277-02) Limited Supply Available. Next Delivery: February 2019; Estimated Recovery: March 2019 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: April 2019; Estimated Recovery: September 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: February 2019; Estimated Recovery: March 2021 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
250 mg/50 mL (5 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4275-01) Available Other
100 mg/2 mL (50 mg/mL); Glass Ampul (NDC 00409-4712-01) Next Delivery and Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
250 mg/50 mL (5 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-4278-01) Available Other
50 mg/5 mL (10 mg/mL); Glass Ampul (NDC 00409-4713-02) Next Delivery and Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay 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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