Drug & medication recalls Moderate risk

Finafta Baby recalled over manufacturing violations

Recall date
August 3, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Product Quest Manufacturing LLC recalls Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miam…
Recall number
D-0079-2019
FDA classification
Class II
Brand / firm
Product Quest Manufacturing LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

CGMP Deviations: products manufactured under conditions that could impact its product quality.

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

What was recalled

Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.

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