Drug & medication recalls Moderate risk

DiBAR LABS Hand Sanitizer 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 DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 5309…
Recall number
D-0645-2021
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

DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico.

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