Prevantics 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) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabsti…

Recall number

D-0572-2022

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) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.