July 2020 FDA Recall Drug by Soluciones Cosmeticas, Sa De Cv
D-1560-2020 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Soluciones Cosmeticas, Sa De Cv on July 14, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in United States and the recall is currently terminated.

Recall Number: D-1560-2020

Reason for Recall
cGMP Deviations
Initiated
07-14-2020
Reported
09-09-2020
Quantity
2,486,400 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86042
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.
Soluciones Cosmeticas, SA 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.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2022
Product Description About Product Description
Full technical description of the product.
Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.