Class II · Moderate risk
Blemish Spot Treatment
Failed Stability Specifications
PCA Skin Blemish Control Bar
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug: Salicylic acid content is above the firm's specification.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
- Recalling firm
- Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0634-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Island Kinetics, Inc. d.b.a. CoValence Laboratories
All 2019 recalls
Class III · Low risk
Essential Calming Skin Gel
Subpotent Drug
Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
Remedy Gel
Subpotent Drug
Other wrong potency / content recalls from 2019
All wrong potency / content recalls
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Class III · Low risk
Class III · Low risk
Class III · Low risk
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