Recall Enforment Report D-0067-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Adam's Polishes LLC, originally initiated on 11-05-2022 for the 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. The product was recalled due to 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 product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0067-2023	11-05-2022	11-23-2022	Class II	3,441 gallons total	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.	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.	Ongoing
D-0066-2023	11-05-2022	11-23-2022	Class I	3,441 gallons total	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.	Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.	Ongoing

Field Name	Field Value
Event ID	91084 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0067-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	3,441 gallons total Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	11-23-2022
Recall Initiation Date	11-05-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Adam's Polishes LLC
Code Info	Lots: 133470, 133471, 133472, 133473, 133474, 133476, 133477, 133478, 133479, 133480, 133481, 133482, 133483, 137731, 137732, 137733, 137734, 139322, 143327 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Ongoing

Field Name	Field Value
Event ID	91084 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0066-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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	Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	3,441 gallons total Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	11-23-2022
Recall Initiation Date	11-05-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Adam's Polishes LLC
Code Info	Lot: 133475 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Ongoing