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Recall Observatory FDA recall evidence

Drug product

PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.

D-0762-2021

July 23, 2021

Class II

Product summary

Firm
Professional Disposables International, Inc
Event
Event 88326
Status
Terminated
Classification
Class II
Quantity
5,477 cases
Official record key
drug-enforcement:D-0762-2021

Official wording

Reason: SubPotent: Out of Specification

Code information: Lot #'s 11901081, EXP 2023-04-04; 11901340, EXP 2023-04-05; 11901593, EXP 2023-04-06; 11901594, EXP 2023-04-07; 12000784, EXP 2023-04-08; 12000992, EXP 2023-04-09; 12001492, EXP 2023-04-10; 12001699, EXP 2023-04-11; 12100121, EXP 2023-04-12; 12100453, EXP 2023-04-13;

Distribution pattern: Distributed Nationwide in the US

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    SubPotent