November 2021 FDA Recall Drug by Medline Industries Inc
D-0287-2022 - Defective Container

This Class II drug recall was voluntarily initiated by Medline Industries Inc on November 8, 2021 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0287-2022

Reason for Recall
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Initiated
11-08-2021
Reported
12-29-2021
Quantity
470,555 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89036
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medline Industries Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA, Canada, Hong Kong, and Peru
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

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