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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Adamis Pharmaceuticals Corporation (Reverified 12/17/2019)

Company Contact Information:
800-230-3935

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Carton containing two SYMJEPI (epinephrine injection, USP) 0.3 mg single-dose, pre-filled syringes (NDC 0781-3442-20) Available
Carton containing two SYMJEPI (epinephrine injection, USP) 0.15 mg single-dose, pre-filled syringes (NDC 0781-3448-20) Available

Impax Laboratories (Revised 06/01/2020)

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) On allocation to current customers.

Dear Healthcare Provider Letter


Patient Inspection Instructions
Manufacturing delays
0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector (two pack)(NDC 0115-1694-49) On allocation to current customers.

Important Safety Information for Healthcare Providers


Important Safety Information for Consumers
Manufacturing delays

Kaleo (Reverified 06/15/2020)

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 06/25/2020)

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, pack of 2; NDC 49502-500-01, individual) (Authorized Generic NDC 49502-102-02, pack of 2; NDC 49502-102-01, individual) Available Production output from Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, has improved in recent months. Supplies are routinely shipping and, as a result, are more consistently available at the pharmacy level. In the event patients experience difficulty accessing product, they can continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.

Dear Healthcare Provider Letter for Extended Expiration Dates for All Lots of EpiPen 0.3 mg Auto-Injectors and its Authorized Generic


Dear Healthcare Provider Letter: Important Safety Information This letter is to communicate important safety information and is not a recall of the product.
0.15 mg (EpiPen® NDC 49502-501-02) (Authorized Generic NDC 49502-101-02) Available Production output from Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, has improved in recent months. Supplies are routinely shipping and, as a result, are more consistently available at the pharmacy level. In the event patients experience difficulty accessing product, they can continue to contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.
Dear Healthcare Provider Letter: Important Safety Information This letter is to communicate important safety information and is not a recall of the product.

Teva Pharmaceuticals (Reverified 06/18/2020)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
0.15 MG Epinephrine Injection, USP auto-injector (NDC 0093-5985-27) Available but sporadic supply interruptions through June, 2020
0.3 mg/mL epinephrine injection, USP, auto-injector (NDC 0093-5986-27) Available but sporadic supply interruptions through June, 2020

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