GoodSense Aller.Ease fexofenadine tablets recalled for impurity specification failure
Perrigo Company PLC is recalling GoodSense Aller.Ease fexofenadine hydrochloride 60 mg tablets nationwide due to failed impurity and degradation specifications identified 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: The FDA classified this as a Class II recall. No illnesses, injuries, or deaths are reported in the source text. The hazard is a failed specification for an unspecified impurity detected during stability testing with no documented patient harm, warranting a Moderate severity rating consistent with Class II recalls lacking reported illness.
Plain-English summary
Perrigo Company PLC is recalling GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets in 24 count bottles nationwide. The recall affects approximately 36,048 containers with lot numbers 0JE2487, 0KE2982, and expiration date 1/31/2022.
The product is being recalled because an out-of-specification result was obtained for impurity A during stability testing. This failure to meet impurity and degradation specifications indicates the product did not meet established quality standards at the time of testing.
The affected product was made in the Czech Republic and distributed by Perrigo Allergan, MI 49010. Consumers who have purchased this product should contact Perrigo Company PLC for instructions on how to proceed.
The recalled product
- Product
- GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.
- Manufacturer
- Perrigo Company PLC
- Hazard
- impurity-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# 0JE2487
- 0KE2982
- Exp 1/31/2022
Distribution
Distributed nationwide across the United States.
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