D-0102-2021 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- December 2, 2020
- Initiation Date
- September 24, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1392 bottles
Product Description
SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .
Reason for Recall
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Distribution Pattern
Texas
Code Information
EXP MAY/2021