ProtectoRx recalled over manufacturing violations

Recall date

May 11, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DIBAR NUTRICIONAL S DE RL DE CV recalls 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-…

Recall number

D-0646-2021

FDA classification

Class II

Brand / firm

DIBAR NUTRICIONAL S DE RL DE CV

Sold / distributed

Distributed Nationwide in the USA

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.