FDA Recall D-0067-2023

Adam's Polishes LLC · Thornton, CO

Class II Ongoing 1286 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

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

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 record

Recall number: D-0067-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA
Recall initiated: 2022-11-05
Classified by FDA Center: 2022-11-22
FDA published: 2022-11-23
Recalling firm: Adam's Polishes LLC
Firm location: Thornton, CO

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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