CLASS II Drug recall · Reported 16 Dec 2020 · FDA Enforcement Report
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a) recalled
Asiaticon is recalling V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a), distributed in Texas. The recall was initiated on 25 Aug 2020 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-0116-2021
- FDA event ID
- 86327
- Recalling firm
- Asiaticon, Ciudad De Mexico, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Aug 2020
- FDA classified
- 7 Dec 2020
- Reported
- 16 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 25 Aug 2020 | Recall initiated by company | |
| 7 Dec 2020 | Classified by FDA | +104 days |
| 16 Dec 2020 | 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
Lack of CGMPs:
Product as listed by the FDA
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ;
Where it was distributed
Distributed in Texas
Questions about this recall
Why was it recalled?
Lack of CGMPs:
Which lots are affected?
All lots.
Where was it sold?
Distributed in Texas
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
1 other product · FDA event 86327| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Protz real protection Antibacterial Hand Sanitizer recalled | Asiaticon | Manufacturing (CGMP) Deviations | TX |
More recalls from Asiaticon
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Protz real protection Antibacterial Hand Sanitizer recalled | Asiaticon | Manufacturing (CGMP) Deviations | TX |