June 2020 FDA Recall Drug by A.p. Deauville, Llc
D-1337-2020 - cGMP Deviations
This Class II drug recall was voluntarily initiated by A.p. Deauville, Llc on June 3, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1337-2020
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
06-03-2020
07-01-2020
82,800 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
A.P. Deauville, 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.
U.S.A. Nationwide
10-26-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097
Batch or Lot Expiration Information
Lot# : 070421E211; 070921E221; 071021E231; 071021E241, Exp 7/2021
