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 12/11/2018)

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 08/03/2018)

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) Currently backordered Additional quantities expected by early October Demand increase for the drug
1% 5 mL Ampoule (NDC 55150-159-74) Currently backordered Additional quantities expected by early September Demand increase for the drug
2% 2 mL Ampoule (NDC 55150-160-72) Currently backordered Additional quantities expected by early October Demand increase for the drug
1% 2 mL Single Dose Vial (NDC 55150-161-02) Currently backordered Additional quantities expected by early September Demand increase for the drug
1% 5 mL Single Dose Vial (NDC 55150-163-30) Currently backordered Additional quantities expected by late September Demand increase for the drug
1% 30 mL Single Dose Vial (NDC 55150-163-30) Currently backordered Additional quantities expected by late September Demand increase for the drug
2% 2 mL Single Dose Vial (NDC 55150-164-02) Currently in stock Intermittent backorders expected Demand increase for the drug
2% 5 mL Single Dose Vial (NDC 55150-165-05) Currently backordered Next shipment TBD 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 early October Demand increase for the drug
2% 10 mL Multi Dose Vial (NDC 55150-254-10) Currently backordered Additional quantities expected by early November Demand increase for the drug
2% 20 mL Multi Dose Vial (NDC 55150-255-20) Currently backordered Additional quantities expected by late October Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 11/28/2018)

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 January 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) Backordered. Next release January 2019. 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 December 2018. 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 December 2018. 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 December 2018. 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 December 2018. 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) Backordered. Next release December 2018. 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 January 2019. 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 anticipated December 2018. 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) Backordered. Next release anticipated December 2018. 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) Backordered. Next release December 2018. 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 January 2019. 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 December 2018. Demand increase for the drug
Xylocaine 1% - MPF injection 10 mg/mL, 2 mL vial (NDC 63323-0492-27) Backordered. Next release December 2018. 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) Backordered. Next release December 2018. 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 January 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

Hospira, Inc. (Revised 12/06/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
50 mg/5 mL (10 mg/mL); Ansyr Plastic Syringe (NDC 00409-9137-05) Next Delivery and Estimated Recovery: December 2018 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) Next Delivery and Estimated Recovery: January 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: December 2018; Estimated Recovery: June 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
300 mg/30 mL (10 mg/mL); Single Dose Glass Teartop Vial (NDC 00409-4279-02) Next Delivery: December 2018; Estimated Recovery: June 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) Next Delivery: December 2018; Estimated Recovery: June 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) Next Delivery: January 2019; Estimated Recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay Other
200 mg/10 mL (20 mg/mL); Glass Ampul (NDC 00409-4282-02) Next Delivery: TBD; Estimated Recovery: June 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: December 2018 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: January 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: January 2019; Estimated Recovery: June 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
1,000 mg/50 mL (20 mg/mL); Multiple Dose Plastic Fliptop Vial (NDC 00409-4277-02) Next Delivery: December 2018; 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: December 2018; Estimated Recovery: June 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: January 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) Next Delivery and Estimated Recovery: March 2019 Shortage per Manufacturer: Manufacturing Delay Other
100 mg/2 mL (50 mg/mL); Glass Ampul (NDC 00409-4712-01) Next Delivery: 2019 and Estimated Recovery: September 2019 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: March 2020; Estimated Recovery: 2020 Shortage per Manufacturer: Manufacturing Delay Other
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

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

West-Ward Pharmaceuticals (Reverified 10/03/2018)

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 are scheduled to be manufactured and available in the October 2018 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 are scheduled to be manufactured and available in the October 2018 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 are scheduled to be manufactured and available in the October 2018 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 are scheduled to be manufactured and available in the October 2018 timeframe. Product will be made available as it is released. Demand increase for the drug

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