PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376
Summary
The FDA issued a Class II for PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable Internat by Professional Disposables International, Inc. Reason: SubPotent: Out of Specification.
Details
Source
Drug Recall
External ID
D-0759-2021
Action Date
2021-09-01
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #'s 11801215, EXP 2021-08-22; 11801504, EXP 2021-11-06; 11801717,EXP 2021-12-07; 11900421, EXP 2022-04-04; 11901076, EXP 2022-08-29; 11901571, EXP 2022-11-19; 12000388, EXP 2023-03-13; 12001533 EXP 2023-07-28; 12100459 EXP 2024-03-31;
Quantity Affected: 1982 cases
Reason for Recall
SubPotent: Out of Specification
Distribution
Distributed Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-23
Company
Woodcliff Lake, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Professional Disposables International, Inc has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Professional Disposables International, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Professional Disposables International, Inc have FDA actions?
Professional Disposables International, Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0759-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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