ProtectoRx — Class II drug recall D-0646-2021
Terminated recall by DIBAR NUTRICIONAL S DE RL DE CV, reported 2021-07-07, distributed nationwide. CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the s
| Recall number | D-0646-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DIBAR NUTRICIONAL S DE RL DE CV, Morelia, N/A, Mexico |
| Recall initiated | 2021-05-11 |
| Classified | 2021-06-29 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2023-03-08 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp |
| NDC | 75408-0002-01, 75408-0002-02 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0646-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.