Major Oral Peroxide — Class III drug recall D-134-2013
Terminated recall by Axcentria Pharmaceuticals LLC, reported 2013-01-30, distributed in MI. Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade
| Recall number | D-134-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Axcentria Pharmaceuticals LLC, Telford, PA, United States |
| Recall initiated | 2012-08-17 |
| Classified | 2013-01-18 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2014-10-07 |
| Distributed | MI |
| Quantity | 17,679 bottles |
| Reason classes | specification failure |
| NDC | 00904-4062-03 |
| Lot numbers | B12019, B12020, D12035, L11065 |
| Expiration dates | 2013-12, 2014-02, 2014-04 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-134-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.