DIBAR NUTRICIONAL S DE RL DE CV: Drug Recall

Recall #D-0647-2021 · 05/11/2021

Class II: Risk

Recall Details

Recall Number: D-0647-2021
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

ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1

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.