FDA recall D-1337-2020

A.P. Deauville, LLC · Class II · drug

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

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status
Terminated
Initiation date
2020-06-03
Report date
2020-07-01
Termination date
2021-10-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
New Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1337-2020