Drug recall D-0572-2021

Class II Terminated reported Jun 2, 2021

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.

Lots and codes

All Lots distributed 02/23/2021 through 03/10/2021.

Recall details

Recalling firm
Cardinal Health Inc., Dublin, OH
Quantity
2907 bottles
Distribution
FL, GA, SC
Type
Voluntary: Firm initiated
Recall initiated
March 15, 2021
Terminated
June 17, 2024

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