Drug 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
D-1565-2020
Product summary
- Event
- Event 86063
- Status
- Terminated
- Classification
- Class II
- Quantity
- 245,500 bottles
- Official record key
drug-enforcement:D-1565-2020
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
presence of undeclared methanol
-
Manufacturing or process control
CGMP Deviations