September 2020 FDA Recall Drug by Ajr Trading Llc
D-1620-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Ajr Trading Llc on September 3, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed in Florida and the recall is currently terminated.

Recall Number: D-1620-2020

Reason for Recall
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Initiated
09-03-2020
Reported
09-30-2020
Quantity
2000 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86388
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.
AJR TRADING LLC
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.
Distributed in Florida
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-04-2023
Product Description About Product Description
Full technical description of the product.
bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5

Batch or Lot Expiration Information

Lot# Lot: 20DF8307 Exp. 04/2022