Food, drugs, devices › Axcentria Pharmaceuticals LLC
Drug recall: Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Dr
FDA enforcement event 62983 is a drug recall by Axcentria Pharmaceuticals LLC of Telford, PA, initiated 17 Aug 2012 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 28% of the 209 drug enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 7 Oct 2014. Initiation: voluntary: firm initiated. Axcentria Pharmaceuticals LLC has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Axcentria Pharmaceuticals LLC, Telford, PA.
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."
Distribution
"MI"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-134-2013 | 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 | 17,679 bottles | Class III | Terminated | 30 Jan 2013 |
Context
Other enforcement events for Axcentria Pharmaceuticals LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Jun 2014 | Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: P | Device | Class II | 1 |
| 5 May 2014 | Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also dist | Drug | Class II | 1 |
| 12 Jul 2012 | Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distr | Drug | Class III | 1 |
All 4 events for Axcentria Pharmaceuticals LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "MI"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.