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
Reported: January 30, 2013 Initiated: August 17, 2012 #D-134-2013
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.
Details
- Recalling Firm
- Axcentria Pharmaceuticals LLC
- Units Affected
- 17,679 bottles
- Distribution
- MI
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Axcentria Pharmaceuticals LLC. Units affected: 17,679 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 30, 2013. Severity: Low. Recall number: D-134-2013.
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