FDA Drug recall D-134-2013
Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48…
- FDA Drug
- Class III
- terminated
- Published 2013-01-30
On 2013-01-30 the FDA classified a Class III recall of Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48… by Axcentria Pharmaceuticals, citing 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 o….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-134-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-08-17 |
| Published | 2013-01-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Axcentria Pharmaceuticals |
| Distribution | MI |
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
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.
Identifiers
| code_info | Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-134-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.