Fexofenadine Hydrochloride Tablets Recall for Failed Impurity Specifications
Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets, 60 mg, 100-count bottles, due to out-of-specification impurity levels 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 failed impurity specifications detected during stability testing. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is based on test results rather than confirmed patient harm. Per the rubric, Class II recalls without reported illness are typically scored as Moderate.
Plain-English summary
Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets, 60 mg, 12-hour antihistamine, in 100-count bottles distributed nationwide in the USA. The recall was initiated because out-of-specification results were obtained for impurity A during stability testing.
The affected product is identified by lot numbers 0CR0510 (expiration 9/30/2021) and 0LR0361 (expiration 04/30/2022). A total of 62,568 containers were distributed. The product was manufactured in the Czech Republic and distributed by Perrigo Allergan, Michigan.
Consumers who have purchased this product should stop using it. Anyone with questions or who believes they have been affected should contact their healthcare provider or pharmacist.
The recalled product
- Product
- basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 2
- Manufacturer
- Perrigo Company PLC
- Hazard
- impurity-degradation
- failed-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 # 0CR0510
- Exp 9/30/2021
- 0LR0361
- Exp 04/30/2022
Distribution
Distributed nationwide across the United States.
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