Prevantics Maxi Swabstick Solution
FDA Recall NDC 10819-4076
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Prevantics Maxi Swabstick (NDC 10819-4076). A significant event, classified as Class II, was initiated on Feb 04, 2022 by Professional Disposables International, Inc.. The reported reason for this action was: "cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Feb 04, 2022
Mar 02, 2022
a) 9518 cases; b) 3347 cases
Recall Profile & Regulatory Data
Event ID
89547
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Professional Disposables International, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide in the USA and Puerto Rico.
Termination Date
Oct 31, 2023
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
10819-4076-4Product
10819-4076-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
