Drug product

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.

D-0067-2023

November 05, 2022

Class II

Product summary

Firm: Adam's Polishes LLC
Event: Event 91084
Status: Ongoing
Classification: Class II
Quantity: 3,441 gallons total
Official record key: drug-enforcement:D-0067-2023

Official wording

Reason: 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.

Code information: Lots: 133470, 133471, 133472, 133473, 133474, 133476, 133477, 133478, 133479, 133480, 133481, 133482, 133483, 137731, 137732, 137733, 137734, 139322, 143327

Distribution pattern: Nationwide in the USA

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

found to contain methanol
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations