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 08/22/2017)

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 03/02/2017)

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) Releasing product; however, the demand is greater than the supply at this time. Please check with your wholesaler for available inventory. Demand increase for the drug

AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Reverified 03/18/2014)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1% 2 mL Ampoule (NDC 55150-158-22) Available All presentations are available Demand increase for the drug
1% 5 mL Ampoule (NDC 55150-159-74) Available All presentations are available demand increase for the drug
2% 2 mL Ampoule (NDC 55150-160-72) Available All presentations are available Demand increase for the drug
1% 2 mL Single Dose Vial (NDC 55150-161-02) Available All presentations are available Demand increase for the drug
1% 5 mL Single Dose Vial (NDC 55150-163-30) Available All presentations are available Demand increase for the drug
1% 30 mL Single Dose Vial (NDC 55150-163-30) Available All presentations are available Demand increase for the drug
2% 2 mL Single Dose Vial (NDC 55150-164-02) Available All presentations are available Demand increase for the drug
2% 5 mL Single Dose Vial (NDC 55150-165-05) Available All presentations are available Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 08/17/2017)

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 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) 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 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 anticipated September 2017. 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 anticipated September 2017. 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) Available 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 anticipated September 2017. 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) Available 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) 5 month dating available for direct and drop ship orders. Next release date 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) 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 anticipated August 2017. 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 anticipated August 2017. 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) 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) 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) Backordered. Next release anticipated September 2017. Check wholesalers for inventory. Demand increase for the drug

Hospira, Inc. (Revised 08/10/2017)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1%; 5mL Ansyr Syringe (NDC 0409-9137-05) Available Shortage per manufacturer: Available Other
1.5%; 20mL Sterile Pack Amp (NDC 0409-4056-01) Discontinued Discontinuation of the manufacture of the drug
1%; 2 mL amp (NDC 0409-4713-32) Available Available Other
1%; 20 mL vial (NDC 0409-4276-01) Available Available Other
1%; 30 mL vial (NDC 0409-4279-02) Available Available Other
1%; 50 mL vial (NDC 0409-4276-02) Limited Supply Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available Other
1%; 30 mL Sterile Pack vial (NDC 0409-4270-01) Next delivery & Estimated recovery TBD Shortage per Manufacturer: Manufacturing Delay. Other
2%; 2 mL amp (NDC 0409-4282-01) Available Available Other
2%; 10 mL amp (NDC 0409-4282-02) Available Available Other
1%; 5 mL Abboject syringe (NDC 0409-4904-34) Available Available Other
2%; 5 mL Abboject syringe (NDC 0409-4903-34) Next delivery: Mid August 2017; Estimated recovery: January 2018 Shortage per Manufacturer: Manufacturing Delay.

Dear Customer Letter

Other
2%; 5 mL vial (NDC 0409-2066-05) Available Available Other
2%; 20 mL vial (NDC 0409-4277-01) Available Available Other
2%; 50 mL vial (NDC 0409-4277-02) Available Available Other
4%; 5 mL amp (NDC 0409-4283-01) Next delivery: Mid September 2017; Estimated recovery: October 2017 Shortage per Manufacturer: Manufacturing Delay. Other
0.4% in 5% Dex; 500mL flex (NDC 0409-7931-24) Discontinued Discontinuation of the manufacturer of the drug
0.4% in 5% Dex; 250mL flex (NDC 0409-7931-32) Discontinued Discontinuation of the manufacturer of the drug
0.8% in 5% Dex; 250mL flex (NDC 0409-7939-32) Discontinued Discontinuation of the manufacturer of the drug
2%; 5mL Ansyr syringe (NDC 0409-1323-05) Next delivery: Early August 2017; Estimated recovery: December 2017 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
0.5%; 50 mL FT vial (NDC 0409-4275-01) Available Available Other
5% w/7.5% Dex; 2mL amp (NDC 0409-4712-01) Next delivery and estimated recovery: 2Q 2018 Shortage per Manufacturer: Manufacturing Delay Other
0.5%; 50 mL TT vial (NDC 0409-4278-01) Available Available Other
1%; 5 mL amp (NDC 0409-4713-02) Next delivery: Late July 2017; Estimated recovery: October 2017 Shortage per Manufacturer: Manufacturing Delay Other

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