D-1590-2020 Class II Terminated

Recalled by GRUPO YACANA MEXICO SAS DE CV — Guadalupe, N/A

FDA drug recall D-1590-2020 was initiated by GRUPO YACANA MEXICO SAS DE CV on August 18, 2020 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated May 17, 2023). Affected quantity: 55,560 bottles.

Recall Details

Product Type
Drugs
Report Date
September 30, 2020
Initiation Date
August 18, 2020
Termination Date
May 17, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55,560 bottles

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

Reason for Recall

cGMP Deviations

Distribution Pattern

TX

Code Information

All lots