# FDA recall D-134-2013

> **Axcentria Pharmaceuticals LLC** · Class III · drug recall initiated 2012-08-17.

## 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.

## Distribution

MI

## Key facts

- **Recall number:** D-134-2013
- **Recalling firm:** Axcentria Pharmaceuticals LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-08-17
- **Report date:** 2013-01-30
- **Termination date:** 2014-10-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Telford, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-134-2013

## Citation

> AI Analytics. FDA recall D-134-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-134-2013. Source: US FDA. Licensed CC0.

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