Class II · Moderate risk
CAREone
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Major Oral Peroxide
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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
Affected NDC
0904-4062-03
Compare with the code on your package — it is the most precise check available.
Drug: Carbamide
- Recalling firm
- Axcentria Pharmaceuticals LLC
- NDC code
- 0904-4062-03
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-134-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Carbamide recalls
See all
Class II · Moderate risk
meijer
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Foster & Thrive
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Leader
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Good Neighbor Pharmacy
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Other recalls by Axcentria Pharmaceuticals LLC
All 2012 recalls
Class II · Moderate risk
Hemo-Stat Solution
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Class III · Low risk
Major brand Infants' Mapap
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
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