December 2019 FDA Recall Drug by Island Kinetics, Inc. D.b.a. Covalence Laboratories
D-0634-2020 - Superpotent Drug

This Class III drug recall was voluntarily initiated by Island Kinetics, Inc. D.b.a. Covalence Laboratories on December 20, 2019 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed in AZ and the recall is currently terminated.

Recall Number: D-0634-2020

Reason for Recall
Superpotent Drug: Salicylic acid content is above the firm's specification.
Initiated
12-20-2019
Reported
01-08-2020
Quantity
2542 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84561
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-25-2021
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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