D-1581-2020 Class II Terminated
FDA drug recall D-1581-2020 was initiated by Real Clean Distribuciones SA de CV on July 23, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Born Basic Anti Bac 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 … The recall status is terminated (terminated May 27, 2022). Affected quantity: 975,720 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 23, 2020
- Initiation Date
- July 23, 2020
- Termination Date
- May 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 975,720 bottles
Product Description
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Reason for Recall
CGMP Deviations: Born Basic Anti Bac 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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lots: a) 0133720, 0233720 b) 0833420, 0933420, 1333420, 1433420, 1533420, 1633420, 1733420, 1833420, 1933420, 2033420, 2133420, 2633420, 2733420, 2833420, 2933420 c) 0133420, 0233420, 0333420, 0433420, 0533420, 0633420