CLASS II Drug recall · Reported 7 Jul 2021 · FDA Enforcement Report
ProtectoRx (ethyl alcohol 70%) recalled by Dibar Nutricional S De Rl De
Dibar Nutricional S De Rl De Cv is recalling ProtectoRx (ethyl alcohol 70%), distributed nationwide in the US. The recall was initiated on 11 May 2021 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-0646-2021
- FDA event ID
- 87917
- Recalling firm
- Dibar Nutricional S De Rl De Cv, Morelia, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2021
- FDA classified
- 29 Jun 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 11 May 2021 | Recall initiated by company | |
| 29 Jun 2021 | Classified by FDA | +49 days |
| 7 Jul 2021 | Published in enforcement report | +8 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: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Product as listed by the FDA
ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is ProtectoRx (ethyl alcohol 70%) recalled?
Yes. Dibar Nutricional S De Rl De Cv recalled ProtectoRx (ethyl alcohol 70%) on 11 May 2021. The recall is Class II and its status is Terminated. Recall number D-0646-2021.
Why was it recalled?
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Which lots are affected?
All lots.
Where was it sold?
Distributed Nationwide in the USA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dibar Nutricional S De Rl De Cv
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) recalled | Dibar Nutricional S De Rl De Cv | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Advance Hand Sanitizer, (ethyl alcohol 70%) recalled | Dibar Nutricional S De Rl De Cv | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | DiBAR LABS Hand Sanitizer (ethyl alcohol 70%) recalled | Dibar Nutricional S De Rl De Cv | Other | Nationwide |