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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.
Where it was sold
MI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-134-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 17, 2012
- FDA report date
- Jan 30, 2013
- Quantity
- 17,679 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Axcentria Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-134-2013, exactly as published.
Show all FDA fields
- City
- Telford
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 62983
- Address
- 306 Keystone Dr
- Address (line 2)
- Unit B
- Code information
- Lot #s L11065, exp 12/2013; B12019, exp 2/2014; B12020, exp 2/2014; and D12035, exp 4/2014.
- Postal code
- 18969
- Report date
- Jan 30, 2013
- Product type
- Drugs
- Recall number
- D-134-2013
- Classification
- Class III
- Recalling firm
- Axcentria Pharmaceuticals LLC
- Product quantity
- 17,679 bottles
- Termination date
- Oct 7, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- MI
- Recall initiation date
- Aug 17, 2012
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2013