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U.S. Department of Health and Human Services

FDA Drug Shortages

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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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 Lidocaine Hydrochloride (Xylocaine) Injection

 Status: Currently in Shortage

 » Date first reported: 02/22/2012
 » Therapeutic Categories: Anesthesia; Pediatric

American Regent/Luitpold (Reverified 10/21/2014)

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 10/21/2014)

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) Amphastar will regularly release products. Amphastar is experiencing a product shortage due to an increase in product demand caused by market supply issues 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 10/24/2014)

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) 8 month dating available by request. 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) 6 month dating available by request. 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 anticipated September 2014. 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 anticipated November 2014. 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 October 2014. Check wholesalers for inventory. Demand increase for the drug
Xylocaine 2% injection 20 mg/mL, 10 mL vial (NDC 63323-0486-10) discontinued 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 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 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) Backordered. Next release anticipated November 2014. Check wholesalers for inventory. Demand increase for the drug
Lidocaine 1% Lidocaine 1% injection 10 mg/mL, 2 mL vial (NDC 63323-0201-02) 6 & 7 month dating available by request. 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 Backordered. Next release anticipated November 2014. 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. 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) Backordered. Next release anticipated November 2014. 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 10/23/2014)

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: TBD 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 October 2014. Estimated recovery 4Q 2014. 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) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1% w/EPI 1:100,000; 30 mL vial (NDC 0409-3178-02) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1% w/EPI 1:100,000; 50 mL vial (NDC 0409-3178-03) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1.5% w/EPI 1:200,000; 5 mL amp (NDC 0409-1209-01) Next delivery October 2014; Estimated recovery 4Q 2014 Please check with your wholesaler for available inventory. Demand increase of the drug
1.5% w/EPI 1:200,000; 30 mL amp (NDC 0409-3181-01) Next delivery: October 2014; Estimated recovery 4Q 2014 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay. Other
2% w/EPI 1:100,000; 20 mL vial (NDC 0409-3182-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
2% w/EPI 1:100,000; 30 mL vial (NDC 0409-3182-02) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
2% w/EPI 1:100,000; 50 mL vial (NDC 0409-3182-03) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
2% w/EPI 1:200,000; 20 mL vial (NDC 0409-3183-01) Next delivery: October 2014; Estimated recovery 4Q 2014 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing Delay. 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 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1.5%; 20mL Sterile Pack Amp (NDC 0409-4056-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1%; 2 mL amp (NDC 0409-4713-32) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1%; 20 mL vial (NDC 0409-4276-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1%; 30 mL vial (NDC 0409-4279-02) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1%; 50 mL vial (NDC 0409-4276-02) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1%; 30 mL Sterile Pack vial (NDC 0409-4270-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
2%; 2 mL amp (NDC 0409-4282-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
2%; 10 mL amp (NDC 0409-4282-02) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1%; 5 mL Abboject syringe (NDC 0409-4904-34) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
2%; 5 mL Abboject syringe (NDC 0409-4903-34) Next delivery November 2014. Estimated recovery 4Q 2014. Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay. Other
2%; 5 mL vial (NDC 0409-2066-05) Next delivery: October 2014; Estimated recovery 4Q 2014. Please check with your wholesaler for available inventory. Shortage per Manufacturer:Manufacturing delay. Other
2%; 20 mL vial (NDC 0409-4277-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
2%; 50 mL vial (NDC 0409-4277-02) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
4%; 5 mL amp (NDC 0409-4283-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
0.4% in 5% Dex; 500mL flex (NDC 0409-7931-24) Next delivery and estimated recovery 2016 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay. Other
0.4% in 5% Dex; 250mL flex (NDC 0409-7931-32) Next delivery and estimated recovery 2016 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay. Other
0.8% in 5% Dex; 250mL flex (NDC 0409-7939-32) Next delivery and estimated recovery 2016 Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay. Other
2%; 5mL Ansyr syringe (NDC 0409-1323-05) Next delivery Late October 2014. Estimated recovery 4Q 2014. Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing Delay. Other
0.5%; 50 mL FT vial (NDC 0409-4275-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
5% w/7.5% Dex; 2mL amp (NDC 0409-4712-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
0.5%; 50 mL TT vial (NDC 0409-4278-01) Available Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available. Other
1%; 5 mL amp (NDC 0409-4713-02) Next delivery November 2014; Estimated recovery 4Q 2014 Please check with your wholesaler for available inventory. Demand increase of the drug
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