D-1337-2020 Class II Terminated

Recalled by A.P. Deauville, LLC — New Brunswick, NJ

FDA drug recall D-1337-2020 was initiated by A.P. Deauville, LLC on June 3, 2020 and is designated Class II. Reason for recall: cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications. The recall status is terminated (terminated October 26, 2021). Affected quantity: 82,800 bottles.

Recall Details

Product Type
Drugs
Report Date
July 1, 2020
Initiation Date
June 3, 2020
Termination Date
October 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82,800 bottles

Product Description

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

Reason for Recall

cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: 070421E211; 070921E221; 071021E231; 071021E241, Exp 7/2021