Cardinal Health Recalls Children's Loratadine Due to Temperature Excursions
Cardinal Health is recalling 2,907 bottles of Children's Loratadine Oral Solution due to intermittent exposure to temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 2,907 bottles of Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL). The product is distributed by Taro Pharmaceuticals U.S.A., Inc. and manufactured by Sun Pharmaceutical Industries, Inc.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected lots were distributed between February 23, 2021, and March 10, 2021.
The product was distributed in Florida, Georgia, and South Carolina. Consumers should check their inventory for the specific NDC 51672-2131-8 and stop using the product if it matches the recalled description.
The recalled product
- Product
- CHILDRENS LORATADINE (LORATADINE)
- Brand
- CHILDRENS LORATADINE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — OTC Antihistamine
- Affected units
- 2,907
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots distributed 02/23/2021 through 03/10/2021.
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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