PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use onl...

FDA Recall #D-0634-2020 — Class III — December 20, 2019

Recall #D-0634-2020 Date: December 20, 2019 Classification: Class III Status: Terminated

Product Description

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.

Recalling Firm

Island Kinetics, Inc. d.b.a. CoValence Laboratories — Chandler, AZ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2542 units

Distribution

AZ

Code Information

Batch number: L041918A, Exp. 04/2021 Lot # F9518B2

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated