FDA recall record

GRUPO YACANA MEXICO SAS DE CV Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz recall — FDA D-1590-2020

cGMP Deviations

Class IIclassification
D-1590-2020official record ID
Sep 30, 2020report date

Recall record at a glance

Official recordD-1590-2020
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmGRUPO YACANA MEXICO SAS DE CV
Report dateSep 30, 2020
Recall initiation dateAug 18, 2020
Quantity55,560 bottles
LocationGuadalupe, N/A, Mexico

Official product description

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

Why the product was recalled

cGMP Deviations

Distribution information

TX

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Press Release.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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