PlainRecalls
FDA Drug Moderate Class II Terminated

Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0528-2021

Product Description

Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
620 injector
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01. Recalled by Cardinal Health Inc.. Units affected: 620 injector.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0528-2021.