D-1565-2020 Class II Terminated
FDA drug recall D-1565-2020 was initiated by Maquiladora Miniara Sa De Cv on July 9, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 24, 2024). Affected quantity: 245,500 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 16, 2020
- Initiation Date
- July 9, 2020
- Termination Date
- April 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 245,500 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
Distributed Nationwide in the USA
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.