Recall Enforment Report D-0287-2022

Recall Details

Drug Recall Enforcement Report Class II voluntary initiated by Medline Industries Inc, originally initiated on 11-08-2021 for the product Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093. The product was recalled due to defective container: customer complaints for leaking bottles and dispensing issues.. The product was distributed nationwide and the recall is currently ongoing.

Field Name	Field Value
Event ID	89036 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0287-2022 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, Canada, Hong Kong, and Peru 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	Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
Reason For Recall	Defective Container: Customer complaints for leaking bottles and dispensing issues. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	470,555 bottles 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	12-29-2021
Recall Initiation Date	11-08-2021 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	Letter 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	Medline Industries Inc
Code Info	Lot #: a) 32890, exp 04/2022; 33141, 33215, exp 10/2022; 33350, exp 12/2022; 33461, exp 03/2023; b) 32858, exp 02/2022; 32889, exp 03/2022; 32968, 32977, 32975, 32984, exp 06/2022; 33294, 33295, 33322, 33323, exp 12/2022; 33384, exp 01/2023; Lot 33620, exp 07/2023; c) 32728, exp 10/2021; 32859, 32889, exp 03/2022; 32985, 32988, 33004, exp 06/2022; 33339, exp 12/2022; 33501, exp 03/2023; 33502, exp 04/2023; 33621, 33622, exp 07/2023 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