Reported Mar 2, 2022 · Terminated
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034…
Professional Disposables International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Professional Disposables International, Inc. · 2 Nice Pak Park · Orangeburg, NY · 10962-1317
Is this the product you have?
- 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.
- Lot codes and dates
178 of 178 codes
Lot #: a) 120001651200016612000382Exp Feb 20221200022812000381120003831200057712000578120005791200066112000662Exp Mar 20221200065912000660Exp Apr 202212001060120010611200106212001100 LE12001101 LEExp Jun 202212001233120012341200123512001236Exp Jul 202212001351120013941200139512001396120013971200139812001399Exp Aug 20221200163212001633120016341200163512001636Exp Sep 202212001637120016381200163912001640120016411200172112001791Exp Oct 202212001792120017931200179412001962Exp Nov 2022120020391200204012100014121000151210001612100017
- Amount recalled
- a) 160531 cases; b) 16123 cases
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
This product could cause temporary or reversible health problems — stop using it.
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