Drug & medication recalls Moderate risk

AVKARE Inc. recalls AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

Recall date
August 28, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1875-2019
FDA classification
Class II
Brand / firm
AVKARE Inc.
Sold / distributed
Nationwide in the U.S.

Why it was recalled

Failed Stability Specifications.

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

What was recalled

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

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