September 2020 FDA Recall Drug by Aa Products Inc
D-0102-2021 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Aa Products Inc on September 24, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Texas and the recall is currently completed.

Recall Number: D-0102-2021

Reason for Recall
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Initiated
09-24-2020
Reported
12-02-2020
Quantity
1392 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86497
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AA PRODUCTS INC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Texas
Product Description About Product Description
Full technical description of the product.
SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .

Batch or Lot Expiration Information

Lot# EXP MAY/2021