Prevantics Maxi Swabstick recalled over manufacturing violations

Recall date

February 4, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Professional Disposables International, Inc. recalls Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Ma…

Recall number

D-0570-2022

FDA classification

Class II

Brand / firm

Professional Disposables International, Inc.

Sold / distributed

Product was distributed nationwide in the USA and Puerto Rico.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.