July 2020 FDA Recall Drug by Maquiladora Miniara Sa De Cv
D-1565-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Maquiladora Miniara Sa De Cv on July 9, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1565-2020

Reason for Recall
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Initiated
07-09-2020
Reported
09-16-2020
Quantity
245,500 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86063
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.
Maquiladora Miniara 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.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-24-2024
Product Description About Product Description
Full technical description of the product.
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01

Batch or Lot Expiration Information

Lot# Lots: F200829088, F200829095, F200829107, D202728743, D202528742, D202428733, D202728743, D2028753, D202528742, D202428733, D202028689, D201828660, D202428734, E200128784, E200418795, D202428734, D202828689, D201828660, E201628912, E201628913, E201628911, E201528902, E201528903, E201628910, E201628918, E201628914, E201628915, E201628916, E201628917, E202328969, E202428975, E202528981, E202128947, E201728918, E201728919, E201428876, E201828894, E201828920, E201428876, E201128850, E201328859, E200628817, E200828826, E200928840, D202128699, D202428700.