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Recall Observatory FDA recall evidence

Drug product

Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03

D-0828-2021

August 26, 2021

Class II

Product summary

Firm
AVRIO HEALTH L.P
Event
Event 88539
Status
Terminated
Classification
Class II
Quantity
75,828 shippers
Official record key
drug-enforcement:D-0828-2021

Official wording

Reason: Subpotent Drug

Code information: Lot # 11901232, Exp. Date 09/30/2021 11901549, Exp. Date 11/30/2021 12000585, Exp. Date 03/31/2022 12000964, Exp. Date 5/31/2022 12001457, Exp. Date 7/31/2022 12002142, Exp. Date 12/31/2022 12100407, Exp. Date 03/31/2023 11901231, Exp. Date 09/30/2021 11901548, Exp. Date 11/30/2021 12000584, Exp. Date 03/31/2022 12000963, Exp. Date 05/31/2022 12001185, Exp. Date 06/30/2022 12001456, Exp. Date 07/31/2022 12002150, Exp. Date 12/31/2022 12100406, Exp. Date 03/31/2023

Distribution pattern: Product was distributed nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent