Drug 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
D-1620-2020
Product summary
- Firm
- AJR TRADING LLC
- Event
- Event 86388
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2000 bottles
- Official record key
drug-enforcement:D-1620-2020
Official wording
Reason: CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Code information: Lot: 20DF8307 Exp. 04/2022
Distribution pattern: Distributed in Florida
Derived failure modes
-
Manufacturing or process control
CGMP Deviations