FDA recall D-0646-2021

DIBAR NUTRICIONAL S DE RL DE CV · Class II · drug

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.

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2021-05-11
Report date: 2021-07-07
Termination date: 2023-03-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Morelia, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2021