FDA-Drug2022-03-02Class II
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 1
Professional Disposables International, Inc.
Hazard
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Sold states
Product was distributed nationwide in the USA and Puerto Rico.
Affected count
a) 9518 cases; b) 3347 cases
Manufactured in
2 Nice Pak Park, Orangeburg, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0570-2022Don't want to check this manually?
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