Prevantics Swab 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) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034…

Recall number

D-0571-2022

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) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.