Professional Disposables International, Inc: Drug Recall

Recall #D-0760-2021 · 07/23/2021

Class II: Risk

Recall Details

Recall Number: D-0760-2021
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: 41,105 cases

Reason for Recall

SubPotent: Out of Specification

Product Description

PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.

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.