Food, drugs, devices › Medline Industries Inc
Drug recall: 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
FDA enforcement event 89036 is a drug recall by Medline Industries Inc of Northfield, IL, initiated 8 Nov 2021 and classified Class II, with 1 product record.
FDA defines Class II as 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. 60% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 28 Aug 2024. Initiation: voluntary: firm initiated. Medline Industries Inc has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medline Industries Inc, Northfield, IL.
Reason for recall
"Defective Container: Customer complaints for leaking bottles and dispensing issues."
Distribution
"Nationwide in the USA, Canada, Hong Kong, and Peru"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0287-2022 | 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. | 470,555 bottles | Class II | Terminated | 29 Dec 2021 |
Context
Other enforcement events for Medline Industries Inc
All 61 events for Medline Industries Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective Container: Customer complaints for leaking bottles and dispensing issues."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA, Canada, Hong Kong, and Peru"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Aug 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.