Why it was recalled
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Product description
INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
Lot numbers, UPCs & expiration codes
Lot #01316L02 6871201301
Where it was sold
AZ, CO and OH.
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-0237-2017
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Dec 6, 2016
- FDA report date
- Jan 4, 2017
- Quantity
- 216 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipher Pharmaceuticals US LLC
Original FDA data
Every field from FDA enforcement report D-0237-2017, exactly as published.
Show all FDA fields
- City
- Daniel Island
- State
- SC
- Status
- Ongoing
- Country
- United States
- Event ID
- 76011
- Address
- 115 Central Island St Ste 300
- Code information
- Lot #01316L02 6871201301
- Postal code
- 29492-7320
- Report date
- Jan 4, 2017
- Product type
- Drugs
- Recall number
- D-0237-2017
- Classification
- Class III
- Recalling firm
- Cipher Pharmaceuticals US LLC
- Product quantity
- 216 boxes
- Reason for recall
- Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
- Distribution pattern
- AZ, CO and OH.
- Recall initiation date
- Dec 6, 2016
- Initial firm notification
- Center classification date
- Dec 28, 2016