Allergyrelief Fexofenadine Tablets Recalled for Impurity Specification Failure
Perrigo Company is recalling allergyrelief Fexofenadine Hydrochloride 24HR tablets due to an out-of-specification result for impurity A 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 drug with a specification failure related to impurities. No illnesses, injuries, or hospitalizations are reported in the source text, and the hazard is a manufacturing quality defect rather than an acute safety threat. This aligns with the "Moderate" classification for low-risk manufacturing or quality issues.
Plain-English summary
Perrigo Company PLC is recalling allergyrelief Fexofenadine Hydrochloride 24HR 1800mg antihistamine tablets due to failed impurities and degradation specifications. An out-of-specification result for impurity A was obtained during stability testing.
The affected product was distributed nationwide in the USA. Affected lots include: (a) Lot 0JE2407, expiration 2/28/2022, packaged as 15-count bottles (NDC 56062-571-22, UPC 0 41415 38973 1); and (b) Lot 1BR0463, expiration 10/31/2022, packaged as 45-count bottles (NDC 56062-571-95, UPC 0 41415 38773 7). A total of 2,280 containers were distributed by Publix Supermarket Inc.
Consumers who have purchased this product should stop use and consult their healthcare provider or pharmacist regarding alternative antihistamine options.
The recalled product
- Product
- allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lak
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Antihistamine
- Hazard
- impurity-specification-failure
- degradation-specification-failure
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 (3)
- Lot a) 0JE2407
- Exp 2/28/2022 b) 1BR0463
- Exp 10/31/2022
Distribution
Distributed nationwide across the United States.
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