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Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceutic...

FDA Recall #D-134-2013 — Class III — August 17, 2012

Recall #D-134-2013 Date: August 17, 2012 Classification: Class III Status: Terminated

Product Description

Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03

Reason for Recall

Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.

Recalling Firm

Axcentria Pharmaceuticals LLC — Telford, PA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

17,679 bottles

Distribution

MI

Code Information

Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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