Product: Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532
Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated: 20210315
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated