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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Island Kinetics, Inc. d.b.a. CoValence Laboratories: PCA Skin Blemish Control Bar Recalled for High Salicylic Acid Content

Agency Publication Date: December 31, 2019
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Summary

Island Kinetics, Inc. (d.b.a. CoValence Laboratories) is recalling 2,542 units of PCA Skin Blemish Control Bar (salicylic acid 2%), an acne cleanser. The recall was initiated because testing found the salicylic acid content is higher than the company's approved specifications, making the drug product superpotent. Consumers who have purchased this product should contact their healthcare provider or pharmacist for guidance regarding any skin irritation or adverse reactions.

Risk

The product contains a concentration of salicylic acid that exceeds safety specifications, which may increase the risk of severe skin irritation, redness, or chemical sensitivity beyond what is expected for a standard acne treatment.

What You Should Do

  1. Check your product packaging for PCA Skin Blemish Control Bar in the 3.2 oz (90g) size with UPC 812025010397.
  2. Verify the batch and lot information on your product: look for Batch number L041918A with Expiration Date 04/2021 and Lot number F9518B2.
  3. Contact your healthcare provider or pharmacist for guidance if you have been using this product or have experienced skin issues.
  4. Return any unused product to the place of purchase for a refund and contact PCA Skin at 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251 for further instructions.
  5. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: PCA Skin Blemish Control Bar (3.2 oz/90g)
Model:
D-0634-2020
UPC Codes:
812025010397
Lot Numbers:
L041918A (Exp. 04/2021)
F9518B2
Date Ranges: Expiration 04/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84561
Status: Resolved
Manufacturer: Island Kinetics, Inc. d.b.a. CoValence Laboratories
Sold By: PCA Skin
Manufactured In: United States
Units Affected: 2542 units
Distributed To: Arizona

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.