Reported Jan 30, 2013 · Terminated
Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise…
Axcentria Pharmaceuticals LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Axcentria Pharmaceuticals LLC · 306 Keystone Dr · Telford, PA · 18969
Is this the product you have?
Major Oral Peroxide (Carbamide Peroxide 10%)2 fl oz (60 mL)
- Distributed by
Major Pharmaceuticals 31778 Enterprise DriveLivoniaMI 48150NDC 0904-4062-03
- Lot codes and dates
Lot #s L11065exp 12/2013B12019exp 2/2014B12020exp 2/2014and D12035exp 4/2014
- Amount recalled
- 17,679 bottles
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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