Major Oral Peroxide Recalled Due to Stability Data Concerns
Axcentria Pharmaceuticals is recalling Major Oral Peroxide because stability data indicates the product degrades below acceptable levels before the printed expiration date.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a stability/efficacy concern rather than an acute safety hazard like contamination or injury.
Plain-English summary
Axcentria Pharmaceuticals LLC is recalling Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL) bottles. The product is distributed by Major Pharmaceuticals. The recall involves 17,679 bottles distributed in Michigan.
The recall is being conducted because stability data indicates that the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging. The affected lots are L11065 (exp 12/2013), B12019 (exp 2/2014), B12020 (exp 2/2014), and D12035 (exp 4/2014).
Consumers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the point of purchase or disposed of according to local regulations.
The recalled product
- Product
- 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
- Manufacturer
- Axcentria Pharmaceuticals LLC
- Category
- Drug — Oral Care
- Affected units
- 17,679
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #s L11065
- exp 12/2013
- B12019
- exp 2/2014
- B12020
- and D12035
- exp 4/2014.
Distribution
Distributed in 1 state:
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