FDA recall D-0634-2020

Island Kinetics, Inc. d.b.a. CoValence Laboratories · Class III · drug

Product

PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.

Reason for recall

Superpotent Drug: Salicylic acid content is above the firm's specification.

Distribution

Key facts

Status: Terminated
Initiation date: 2019-12-20
Report date: 2020-01-08
Termination date: 2021-08-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chandler, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0634-2020