D-1593-2020 Class II Terminated
FDA drug recall D-1593-2020 was initiated by Nanomateriales Sa De Cv on August 18, 2020 and is designated Class II. Reason for recall: GMP Deviations: Potential to contain 1-propanol. The recall status is terminated (terminated July 5, 2024). Affected quantity: 1,000 kg.
Recall Details
- Product Type
- Drugs
- Report Date
- September 30, 2020
- Initiation Date
- August 18, 2020
- Termination Date
- July 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,000 kg
Product Description
Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. NDC 69912-006-01
Reason for Recall
GMP Deviations: Potential to contain 1-propanol.
Distribution Pattern
CA, NY and Mexico
Code Information
All lots