DIBAR NUTRICIONAL S DE RL DE CV: Drug Recall

Recall #D-0646-2021 · 05/11/2021

Class II: Risk

Recall Details

Recall Number: D-0646-2021
Classification: Class II
Product Type: Drug
Recalling Firm: DIBAR NUTRICIONAL S DE RL DE CV
Status: Terminated
Date Initiated: 05/11/2021
Location: Morelia, N/A, Mexico
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Unknown quantity

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.

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.

Distribution Pattern

Distributed Nationwide in the USA

Other Recalls by DIBAR NUTRICIONAL S DE RL DE CV

Class I: Dangerous 05/11/2021

Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Class II: Risk 05/11/2021

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: Risk 05/11/2021

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.

View all recalls by DIBAR NUTRICIONAL S DE RL DE CV →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.