CLASS II Drug recall · Reported 8 Feb 2023 · FDA Enforcement Report
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine recalled
Frenda is recalling Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, distributed in Puerto Rico. The recall was initiated on 15 Dec 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0254-2023
- FDA event ID
- 91325
- Recalling firm
- Frenda, Trujillo Alto, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Dec 2022
- FDA classified
- 30 Jan 2023
- Reported
- 8 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hand Sanitizer
Timeline
| 15 Dec 2022 | Recall initiated by company | |
| 30 Jan 2023 | Classified by FDA | +46 days |
| 8 Feb 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations
Product as listed by the FDA
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9
Where it was distributed
Puerto Rico
Questions about this recall
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot: C013121
Where was it sold?
Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 91325This product is part of a recall event; the main page for the event is Easy Clean Alcohol Mult Surface Disinfecting Cleaner recalled by Frenda.