Children's Loratadine Oral Solution USP recall: CGMP Deviations
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
Why was Children's Loratadine Oral Solution USP recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots distributed 02/23/2021 through 03/10/2021.
- 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
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 2907 bottles
- Distribution
- FL, GA, SC
- Recall date
- June 2, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)