D-0329-2023 Class III Terminated
FDA drug recall D-0329-2023 was initiated by Advantice Health, Llc on February 2, 2023 and is designated Class III. Reason for recall: Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. The recall status is terminated (terminated October 31, 2023). Affected quantity: 16,152 cans/673 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- March 1, 2023
- Initiation Date
- February 2, 2023
- Termination Date
- October 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,152 cans/673 cases
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
Reason for Recall
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Distribution Pattern
Product was distributed via the internet, distributors and retailers nationwide.
Code Information
Lot # 22336A