Reported Mar 2, 2022 · Terminated
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One…
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) 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.
- Lot codes and dates
Lot #: a) 12000315Exp Feb 202212000700Exp Mar 202212001112 LEExp Jun 202212001214Exp Jul 20221200136212001406Exp Aug 202212001628Exp Sep 202212001856Exp Oct 202212002103Exp Dec 20221200211312100024Exp Jan 20231210022612100227Exp Feb 20231210044312100503Exp Mar 20231210051612100517Exp Apr 20231210074812100756Exp May 2023b) 12001113 LEExp Jun 20221200128912001240Exp Jul 202212002104Exp Dec 202212100025Exp Jan 202312100405Exp Mar 202312100674Exp Apr 202312100779Exp May 2023
- Amount recalled
- a) 9518 cases; b) 3347 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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