D-0067-2023 Class II Ongoing
FDA drug recall D-0067-2023 was initiated by Adam's Polishes LLC on November 5, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. The recall status is ongoing. Affected quantity: 3,441 gallons total.
Recall Details
- Product Type
- Drugs
- Report Date
- November 23, 2022
- Initiation Date
- November 5, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,441 gallons total
Product Description
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.
Reason for Recall
CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: 133470, 133471, 133472, 133473, 133474, 133476, 133477, 133478, 133479, 133480, 133481, 133482, 133483, 137731, 137732, 137733, 137734, 139322, 143327