Status
Terminated
Drug Enforcement D-0329-2023
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Classification
Class III
Report Date
March 1, 2023
Termination Date
October 31, 2023
Product Information
- 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
- Product quantity
- 16,152 cans/673 cases
- Reason for recall
- Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed via the internet, distributors and retailers nationwide.
Location & Firm
- Recalling firm
- Advantice Health, Llc
- Address
-
7 E Frederick Pl Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0329-2023
- Event ID
- 91581
- Recall initiation date
- February 2, 2023
- Center classification date
- February 17, 2023
- Code info
- Lot # 22336A
- More code info
- —