D-1580-2020 Class II Terminated
FDA drug recall D-1580-2020 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: 917,280 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
- 917,280 bottles
Product Description
scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 40038 21434 1
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: 1633220, 1733220, 1833220, 1933220, 2033220, 2133220, 2233220, 2333220, 2433220, 2533220, 2633220, 2733220, 2833220, 2933220, 3033220, 3133220, 3233220, 3333220, 3433220, 3533220, 3633220, 3733220, 3833220, 3933220, 4033220, 4133220