Drug & medication recalls Moderate risk

Taro Pharmaceuticals U.S.A., Inc. recalls Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drow…

Recall date
December 30, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0383-2015
FDA classification
Class II
Brand / firm
Taro Pharmaceuticals U.S.A., Inc.
Sold / distributed
Nationwide

Why it was recalled

Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

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

What was recalled

Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.

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