February 2023 FDA Recall Dermoplast First Aid by Advantice Health, Llc
D-0329-2023 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Advantice Health, Llc on February 2, 2023 for the product Dermoplast First Aid. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0329-2023
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
02-02-2023
03-01-2023
16,152 cans/673 cases
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Advantice Health, Llc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed via the internet, distributors and retailers nationwide.
10-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 22336A
