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Recall Observatory FDA recall evidence

Drug product

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

D-0759-2021

July 23, 2021

Class II

Product summary

Firm
Professional Disposables International, Inc
Event
Event 88326
Status
Terminated
Classification
Class II
Quantity
1982 cases
Official record key
drug-enforcement:D-0759-2021

Official wording

Reason: SubPotent: Out of Specification

Code information: 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;

Distribution pattern: Distributed Nationwide in the US

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    SubPotent