Kroger Allergy Relief Fexofenadine Tablets Recalled for Impurity
Perrigo Company is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 60mg tablets due to an out-of-specification impurity detected during stability testing.
What this means for you
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: This is an FDA Class II recall involving a pharmaceutical product with an out-of-specification impurity. No hospitalizations, illnesses, or injuries are reported in the source text. The recall is precautionary based on a stability testing failure, making it a moderate-severity situation.
Plain-English summary
Perrigo Company PLC is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 12HR 60mg antihistamine tablets, 12 count bottles, distributed nationwide in the United States. The recall was initiated because an out-of-specification result for impurity A was obtained during stability testing, indicating the product failed impurities and degradation specifications.
The affected product was distributed by Kroger CO., Cincinnati, Ohio. The recalled lots are 0LE2178 (expiration 1/31/2022) and 0ME2516 (expiration 4/30/2022), with NDC 30142-555-53 and UPC 0 41260 35588 2. Approximately 48,816 containers are subject to this recall.
Consumers with this product should stop using it. Those with questions about the recall should contact their pharmacy or healthcare provider.
The recalled product
- Product
- Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Antihistamine Tablet
- Hazard
- impurity-degradation
- out-of-specification
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 (4)
- lot 0LE2178
- Exp 1/31/2022
- 0ME2516
- Exp 4/30/2022
Distribution
Distributed nationwide across the United States.
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