Drug & medication recalls Moderate risk

CareOne 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 CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Lando…
Recall number
D-0029-2019
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

CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8.

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