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Recall Observatory FDA recall evidence

Drug 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

D-1569-2020

July 02, 2020

Class II

Product summary

Firm
AAA Cosmetica, SA de CV
Event
Event 86037
Status
Terminated
Classification
Class II
Quantity
21,228 bottles
Official record key
drug-enforcement:D-1569-2020

Official wording

Reason: CGMP Deviations

Code information: Lots: All lots to include 20DF9005, 20DF9006, EXP April 2022

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations