Professional Disposables International, Inc.: Drug Recall

Recall #D-0572-2022 · 02/04/2022

Class II: Risk

Recall Details

Recall Number
D-0572-2022
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) 28201 cases; b) 7579 cases; c) 8882 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) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; 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.

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.