Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick Recalled by Professional Disposables International, Inc. Due to cGMP deviations: uncertainty of the adequacy of the...

Date: February 4, 2022
Company: Professional Disposables International, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Professional Disposables International, Inc. directly.

Affected Products

Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.

Quantity: a) 9518 cases; b) 3347 cases

Why Was This Recalled?

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Professional Disposables International, Inc.

Professional Disposables International, Inc. has 3 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report