Berkley Jensen Fexofenadine Tablets Recalled for Impurity Specification Failure
Perrigo Company PLC is recalling Berkley Jensen Allergy Relief 180 mg fexofenadine tablets due to an impurity specification failure detected during stability testing. The recall affects 7,670 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 involving an out-of-specification impurity finding during stability testing with no reported illnesses or injuries. The source text does not indicate hospitalization or serious injury, placing it in the Moderate category per the rubric.
Plain-English summary
Perrigo Company PLC is recalling Berkley Jensen Allergy Relief Fexofenadine Hydrochloride Tablets 180 mg in 150-count bottles due to failed impurities and degradation specifications. Stability testing detected an out-of-specification result for impurity A.
The affected product is a 24-hour antihistamine medication made in the Czech Republic and distributed by BJ's Wholesale Club (25 Research Drive, Westborough, MA 01581). The recall covers 7,670 containers with lot numbers 0HV1442 (expiration 3/1/2022) and 1CV1619 (expiration 10/1/2022) that were distributed nationwide in the USA.
Consumers with affected medication should stop use and contact the recalling firm or their healthcare provider for guidance.
The recalled product
- Product
- berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581
- Manufacturer
- Perrigo Company PLC
- Hazard
- impurity-specification-failure
- degradation
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 # 0HV1442
- Exp 3/1/2022
- 1CV1619
- Exp 10/1/2022
Distribution
Distributed nationwide across the United States.
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