Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored S...
FDA Recall #D-0383-2015 — Class II — December 30, 2014
Product Description
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.
Reason for Recall
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
36,684 Bottles
Distribution
Nationwide
Code Information
Lot #: A4105, Exp 12/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated