PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: July 7, 2021 Initiated: May 11, 2021 #D-0646-2021

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.

Details

Units Affected
Unknown quantity
Distribution
Distributed Nationwide in the USA
Location
Morelia, N/A

Frequently Asked Questions

What product 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.. Recalled by DIBAR NUTRICIONAL S DE RL DE CV. Units affected: Unknown quantity.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on July 7, 2021. Severity: Moderate. Recall number: D-0646-2021.

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