Drug product
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
D-0329-2023
Product summary
- Event
- Event 91581
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,152 cans/673 cases
- Official record key
drug-enforcement:D-0329-2023
Official wording
Reason: Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Code information: Lot # 22336A
Distribution pattern: Product was distributed via the internet, distributors and retailers nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent