Professional Disposables International, Inc: Drug Recall

Recall #D-0759-2021 · 07/23/2021

Class II: Risk

Recall Details

Recall Number: D-0759-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Professional Disposables International, Inc
Status: Terminated
Date Initiated: 07/23/2021
Location: Woodcliff Lake, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1982 cases

Reason for Recall

SubPotent: Out of Specification

Product Description

PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154

Distribution Pattern

Distributed Nationwide in the US

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 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

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.