Recalls / Class II
Class IID-0079-2021
Product
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6
- Affected lot / code info
- 1931104AL
Why it was recalled
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Recalling firm
- Firm
- Albek De Mexico S.A. De C.V.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- Oriente Cuatro No. 11 Nuevo, N/A, San Juan Del Rio, N/A N/A, Mexico
Distribution
- Quantity
- 2,760 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-07-30
- FDA classified
- 2020-11-17
- Posted by FDA
- 2020-11-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0079-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.