Recalls / Class II
Class IID-0570-2022
Product
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.
- Brand name
- Prevantics Maxi Swabstick
- Generic name
- Chlorhexidine Gluconate And Isopropyl Alcohol
- Active ingredients
- Chlorhexidine Gluconate, Isopropyl Alcohol
- Route
- Topical
- NDC
- 10819-4076
- FDA application
- NDA021524
- Affected lot / code info
- Lot #: a) 12000315, Exp Feb 2022; 12000700, Exp Mar 2022; 12001112 LE, Exp Jun 2022; 12001214, Exp Jul 2022; 12001362, 12001406, Exp Aug 2022; 12001628, Exp Sep 2022; 12001856, Exp Oct 2022; 12002103, Exp Dec 2022; 12002113, 12100024, Exp Jan 2023; 12100226, 12100227, Exp Feb 2023; 12100443, 12100503, Exp Mar 2023; 12100516, 12100517, Exp Apr 2023; 12100748, 12100756, Exp May 2023; b) 12001113 LE, Exp Jun 2022; 12001289, 12001240, Exp Jul 2022; 12002104, Exp Dec 2022; 12100025, Exp Jan 2023; 12100405, Exp Mar 2023; 12100674, Exp Apr 2023; 12100779, Exp May 2023
Why it was recalled
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Recalling firm
- Firm
- Professional Disposables International, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Nice Pak Park, Orangeburg, New York 10962-1317
Distribution
- Quantity
- a) 9518 cases; b) 3347 cases
- Distribution pattern
- Product was distributed nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2022-02-04
- FDA classified
- 2022-02-18
- Posted by FDA
- 2022-03-02
- Terminated
- 2023-10-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0570-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.