Drug product
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 .
D-0102-2021
Product summary
- Firm
- AA PRODUCTS INC
- Event
- Event 86497
- Status
- Completed
- Classification
- Class II
- Quantity
- 1392 bottles
- Official record key
drug-enforcement:D-0102-2021
Official wording
Reason: CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Code information: EXP MAY/2021
Distribution pattern: Texas
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
subpotent