FDA Drug Recalls

Recalls / Class II

Class IID-0287-2022

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.

Affected lot / 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

Why it was recalled

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

Recalling firm

Firm
Medline Industries Inc
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
3 Lakes Dr, N/A, Northfield, Illinois 60093-2753

Distribution

Quantity
470,555 bottles
Distribution pattern
Nationwide in the USA, Canada, Hong Kong, and Peru

Timeline

Recall initiated
2021-11-08
FDA classified
2021-12-17
Posted by FDA
2021-12-29
Terminated
2024-08-28
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0287-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.