Drug Enforcement D-0067-2023

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.

Status

Ongoing

Classification

Class II

Report Date

November 23, 2022

Termination Date

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Product Information

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.
Product quantity
3,441 gallons total
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.
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Adam's Polishes LLC
Address
8225 N Valley Hwy, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0067-2023
Event ID
91084
Recall initiation date
November 5, 2022
Center classification date
November 22, 2022
Code info
Lots: 133470, 133471, 133472, 133473, 133474, 133476, 133477, 133478, 133479, 133480, 133481, 133482, 133483, 137731, 137732, 137733, 137734, 139322, 143327
More code info
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