D-0646-2021 Class II Terminated
FDA drug recall D-0646-2021 was initiated by DIBAR NUTRICIONAL S DE RL DE CV on May 11, 2021 and is designated Class II. 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. The recall status is terminated (terminated Mar 8, 2023). Affected quantity: Unknown quantity.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 7, 2021
- Initiation Date
- May 11, 2021
- Termination Date
- Mar 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown quantity
Product description
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.
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.
Distribution pattern
Distributed Nationwide in the USA
Code information
All lots.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0646-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026