Multi-event August 2020 FDA Recall Drug by Grupo Yacana Mexico Sas De Cv

This Multi-event Class II drug recall was voluntarily initiated by Grupo Yacana Mexico Sas De Cv on August 18, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in TX and the recall is currently terminated.

Reported Recall Events

D-1590-2020 TERMINATED D-1591-2020 TERMINATED

Recall Number: D-1590-2020

Reason for Recall
cGMP Deviations
Initiated
08-18-2020
Reported
09-30-2020
Quantity
55,560 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86271
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GRUPO YACANA MEXICO SAS DE CV
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-17-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# All lots

Recall Number: D-1591-2020

Reason for Recall
cGMP Deviations
Initiated
08-18-2020
Reported
09-30-2020
Quantity
43,728 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86271
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GRUPO YACANA MEXICO SAS DE CV
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-17-2023
Product Description About Product Description
Full technical description of the product.
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0

Batch or Lot Expiration Information

Lot# All lots