Banophen Diphenhydramine HCl 25 mg Antihistamine 100 recall: CGMP Deviations
Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA
Why was Banophen Diphenhydramine HCl 25 mg Antihistamine 100 recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots distributed 02/23/2021 through 03/10/2021
- Product
- Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 88 bottles
- Distribution
- FL, GA, SC
- Recall date
- June 2, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)