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Recall Observatory FDA recall evidence

Drug 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.

D-0287-2022

November 08, 2021

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 89036
Status
Terminated
Classification
Class II
Quantity
470,555 bottles
Official record key
drug-enforcement:D-0287-2022

Official wording

Reason: Defective Container: Customer complaints for leaking bottles and dispensing issues.

Code 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

Distribution pattern: Nationwide in the USA, Canada, Hong Kong, and Peru

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Customer complaints for leaking bottles and dispensing issues.