Multi-event July 2020 FDA Recall Drug by Aaa Cosmetica, Sa De Cv
This Multi-event Class II drug recall was voluntarily initiated by Aaa Cosmetica, Sa De Cv on July 2, 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.
Reported Recall Events
Recall Number: D-1569-2020
CGMP Deviations
07-02-2020
09-09-2020
21,228 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AAA Cosmetica, SA de CV
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
01-16-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
Batch or Lot Expiration Information
Lot# Lots: All lots to include 20DF9005, 20DF9006, EXP April 2022
Recall Number: D-1570-2020
Chemical Contamination: Product contains methanol.
07-02-2020
09-09-2020
204,768 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AAA Cosmetica, SA de CV
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
01-16-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
Batch or Lot Expiration Information
Lot# Lots: 20DF9001, 20DF9002, 20DF9003, 20DF9004, 20DF9007, 20DF9008, 20DF9009, 20DF9010, 20DF9011, 20DF9012, 20DF9013, 20DF9014, 20DF9015, 20DF9016, 20DF9017, 20DF9018, 20DF9019, 20DF9020, 20DF9021, 20DF9022, EXP April 2022
