Why it was recalled
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Product description
Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01
Lot numbers, UPCs & expiration codes
Lot # 22336A
Where it was sold
Product was distributed via the internet, distributors and retailers nationwide.
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-0329-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 2, 2023
- FDA report date
- Mar 1, 2023
- Quantity
- 16,152 cans/673 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advantice Health, Llc
Original FDA data
Every field from FDA enforcement report D-0329-2023, exactly as published.
Show all FDA fields
- City
- Cedar Knolls
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91581
- Address
- 7 E Frederick Pl Ste 100
- Code information
- Lot # 22336A
- Postal code
- 07927-1815
- Report date
- Mar 1, 2023
- Product type
- Drugs
- Recall number
- D-0329-2023
- Classification
- Class III
- Recalling firm
- Advantice Health, Llc
- Product quantity
- 16,152 cans/673 cases
- Termination date
- Oct 31, 2023
- Reason for recall
- Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01
- Distribution pattern
- Product was distributed via the internet, distributors and retailers nationwide.
- Recall initiation date
- Feb 2, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 17, 2023