Professional Disposables International, Inc.: Drug Recall

Recall #D-0570-2022 · 02/04/2022

Class II: Risk

Recall Details

Recall Number: D-0570-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Professional Disposables International, Inc.
Status: Terminated
Date Initiated: 02/04/2022
Location: Orangeburg, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 9518 cases; b) 3347 cases

Reason for Recall

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

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.

Distribution Pattern

Product was distributed nationwide in the USA and Puerto Rico.

Other Recalls by Professional Disposables International, Inc.

Class II: Risk 02/04/2022

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II: Risk 02/04/2022

cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II: Risk 07/23/2021

SubPotent: Out of Specification
Class II: Risk 07/23/2021

SubPotent: Out of Specification
Class II: Risk 07/23/2021

SubPotent: Out of Specification

View all recalls by Professional Disposables International, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.