FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Epinephrine Injection, Auto-Injector
Status: Currently in Shortage
»Date first posted: 05/09/2018
»Therapeutic Categories: Pulmonary/Allergy

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Impax Laboratories (Revised 10/25/2018)

Company Contact Information:
877-99-Impax(46729); option 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1695-49) Available

Dear Healthcare Provider Letter


Patient Inspection Instructions
Dear Healthcare Provider Letter for Expiry Extension for Select Lots of Epinephrine 0.15 mg and 0.30 mg Auto-Injectors
Manufacturing delays
0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1694-49) Available

Dear Healthcare Provider Letter


Patient Inspection Instructions
Dear Healthcare Provider Letter for Expiry Extension for Select Lots of Epinephrine 0.15 mg and 0.30 mg Auto-Injectors
Manufacturing delays

Kaleo (Reverified 11/28/2018)

Company Contact Information:
877-30-AUVIQ (1-877-302-8847)

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Carton containing two AUVI-Q (epinephrine injection, USP) 0.3 mg auto-injectors and a single AUVI-Q Trainer (NDC 60842-023-01) Available AUVI-Q is readily available and not currently in shortage.
Carton containing two AUVI-Q (epinephrine injection, USP) 0.15 mg auto-injectors and a single AUVI-Q Trainer (NDC 60842-022-01) Available AUVI-Q is readily available and not currently in shortage.
Carton containing two AUVI-Q (epinephrine injection, USP) 0.1 mg auto-injectors and a single AUVI-Q Trainer (NDC 60842-021-01) Available AUVI-Q is readily available and not currently in shortage.

Mylan Specialty (Reverified 12/07/2018)

Company Contact Information:
800-RXMYLAN (1-800-796- 9526)

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.3 mg (EpiPen® NDC 49502-500-02) (Authorized Generic NDC 49502-102-02) Available Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen® and the authorized generic version, continues to experience manufacturing constraints. Currently, supplies will vary from pharmacy to pharmacy. Mylan, the distributor, is expediting shipments to wholesalers upon receipt from Pfizer. Patients who are experiencing difficulty accessing product should continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.

Dear Healthcare Provider Letter for Expiry Extension for Select Lots of EpiPen 0.3 mg Auto-Injectors and its Authorized Generic


Dear Healthcare Provider Letter for Potential Label Defect of EpiPen Auto-Injectors and its Authorized Generic
Manufacturing delays
0.15 mg (EpiPen® NDC 49502-501-02) (Authorized Generic NDC 49502-101-02) Available Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen® and the authorized generic version, continues to experience manufacturing constraints. Currently, supplies will vary from pharmacy to pharmacy. Mylan, the distributor, is expediting shipments to wholesalers upon receipt from Pfizer. Patients who are experiencing difficulty accessing product should continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.

Dear Healthcare Provider Letter for Potential Label Defect of EpiPen Auto-Injectors and its Authorized Generic

Manufacturing delays

Teva Pharmaceuticals (New 12/07/2018)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.3 mg/mL epinephrine injection, USP, auto-injector (NDC 0093-5986-27) Available

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