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 01/10/2017)

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 (Reverified 01/18/2017)

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) Product available Demand increase for the drug

Aurobindo Pharma (Reverified 03/18/2014)

Company Contact Information:
800-645-1706

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 01/13/2017)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Xylocaine w/EPI 10 mL, 100 mg MDV (NDC 63323-0482-17) Backordered. Next release anticipated April 2017. Check wholesalers for inventory.

Dear Customer Letter

Manufacturing delay
Xylocaine w/EPI 10 mL, 100mg SDV, MPF (NDC 63323-0487-17) Backordered. Next release anticipated April 2017. Check wholesalers for inventory.

Dear Customer Letter

Manufacturing delay
Xylocaine w/EPI 10 mL, 150 mg, SDV, MPF (NDC 63323-0488-17) Backordered. Next release anticipated April 2017. Check wholesalers for inventory.

Dear Customer Letter

Manufacturing delay
Xylocaine w/EPI 10 mL, 200 mg, SDV, MPF (NDC 63323-0489-17) Backordered. Next release anticipated April 2017. Check wholesalers for inventory.

Dear Customer Letter

Manufacturing delay
Lidocaine 1.5% Xylocaine 1.5% - MPF injection 15 mg/mL, 10 mL ampule (NDC 63323-0493-97) Backordered. Next release anticipated January 2017. 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) Available 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. 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) 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) 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) 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) Available Check wholesalers for inventory. Demand increase for the drug
Xylocaine 1% injection 10 mg/mL, 20 mL vial (NDC 63323-0485-27) Available 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 anticipated January 2017. 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. 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 1% - MPF injection 10 mg/mL, 5 mL glass ampule (NDC 63323-0492-89) Backordered. No release expectations 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 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) Available Check wholesalers for inventory. Demand increase for the drug

Hospira, Inc. (Revised 01/09/2017)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.5% w/EPI 1:100,000; 1.8 mL Carpule (NDC 0409-0996-01) Estimated delivery and recovery: 2017 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay. Other
0.5% w/EPI 1:200,000; 50 mL vial (NDC 0409-3177-01) Next delivery: Early March 2017; Estimated recovery: 2Q 2017 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing Delay. Other
1% w/EPI 1:100,000; 20 mL vial (NDC 0409-3178-01) Next delivery: Early March 2017; Estimated recovery: 1Q 2017 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing Delay. Other
1% w/EPI 1:100,000; 30 mL vial (NDC 0409-3178-02) Next Delivery: Early February 2017; Estimated Recovery: 2Q 2017 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing Delay. Other
1% w/EPI 1:100,000; 50 mL vial (NDC 0409-3178-03) Next Delivery: Early February 2017; Estimated Recovery: 2Q 2017 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing Delay. Other
1.5% w/EPI 1:200,000; 5 mL amp (NDC 0409-1209-01) Available Available Other
1.5% w/EPI 1:200,000; 30 mL amp (NDC 0409-3181-01) Available Available Other
2% w/EPI 1:100,000; 20 mL vial (NDC 0409-3182-01) Available Available Other
2% w/EPI 1:100,000; 30 mL vial (NDC 0409-3182-02) Available Available Other
2% w/EPI 1:100,000; 50 mL vial (NDC 0409-3182-03) Available Available Other
2% w/EPI 1:200,000; 20 mL vial (NDC 0409-3183-01) Available Available Other
2% w Epi 1:50,000; 1.8mL syringe (NDC 0409-7263-01) Estimated delivery and recovery TBD Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay. Other
1%; 5mL Ansyr Syringe (NDC 0409-9137-05) Available 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) Available Available Other
1%; 30 mL Sterile Pack vial (NDC 0409-4270-01) Next delivery & Estimated recovery TBD Please check with your wholesaler for available inventory. 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) Available Available Other
2%; 5 mL vial (NDC 0409-2066-05) Next delivery: Late January 2017; Estimated recovery: 1Q 2017 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay. 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) Available Available 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) Available Available 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 Please check with your wholesaler for available inventory. 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) Available Available Other

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