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Recall Observatory FDA recall evidence

Drug product

PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.

D-0763-2021

July 23, 2021

Class II

Product summary

Firm
Professional Disposables International, Inc
Event
Event 88326
Status
Terminated
Classification
Class II
Quantity
3,113 cases
Official record key
drug-enforcement:D-0763-2021

Official wording

Reason: SubPotent: Out of Specification

Code information: Lot #'s 11901080, EXP 2023-04-14; 11901339, EXP 2023-04-15; 11901755, EXP 2023-04-16; 12000016, EXP 2023-04-17; 12000397, EXP 2023-04-18; 12000987, EXP 2023-04-19; 12001578, EXP 2023-04-20; 12001814, EXP 2023-04-21;

Distribution pattern: Distributed Nationwide in the US

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    SubPotent