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Recall Observatory FDA recall evidence

Drug product

Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3

D-1590-2020

August 18, 2020

Class II

Product summary

Firm
GRUPO YACANA MEXICO SAS DE CV
Event
Event 86271
Status
Terminated
Classification
Class II
Quantity
55,560 bottles
Official record key
drug-enforcement:D-1590-2020

Official wording

Reason: cGMP Deviations

Code information: All lots

Distribution pattern: TX

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations