FDAFebruary 4, 2022drug

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

professional disposablesprofessional

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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