FDA-Drug2021-06-02Class II

Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA

Cardinal Health Inc.
Hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Sold states
FL, GA, SC
Affected count
88 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0512-2021

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