Health Mart Fexofenadine Tablets Recalled for Failed Impurity Specifications
Perrigo Company PLC is recalling Health Mart Fexofenadine Hydrochloride 12HR 60mg tablets due to impurity A exceeding specification limits during stability testing. The recall affects 12,384 containers distributed nationwide.
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 for a manufacturing or quality control defect. The source text does not report any illnesses, injuries, or adverse events associated with the impurity exceedance, making this a precautionary quality-based recall rather than a direct safety threat with demonstrated harm.
Plain-English summary
Perrigo Company PLC is recalling Health Mart Fexofenadine Hydrochloride tablets, 12HR, 60mg antihistamine in 12-count bottles. The recall is due to failed impurities and degradation specifications, specifically an out-of-specification result obtained for impurity A during stability testing.
The affected product was distributed nationwide in the USA. The recalled lot is 0JE2491 with an expiration date of 1/31/2022. The product has the following identifiers: NDC 62011-0413-1, UPC 0 52569 14278 3. The product was made in the Czech Republic and distributed by McKesson, 6555 State Highway 161, Irvine, TX 75039.
Consumers who have purchased this product should stop use and consult their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.
The recalled product
- Product
- Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Antihistamine
- Hazard
- impurity-specification
- degradation-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 (2)
- Lot 0JE2491
- Exp 1/31/2022
Distribution
Distributed nationwide across the United States.
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