Perrigo Fexofenadine Hydrochloride Tablets Recall for Impurity Contamination
Perrigo Company PLC is recalling Fexofenadine Hydrochloride 60mg antihistamine tablets (100-count bottles) nationwide due to failed impurity specifications found during stability testing. The recall affects 41,472 containers distributed in the USA.
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 failed impurity/degradation specifications discovered during stability testing. No illnesses or injuries are reported in the source text, and the hazard is quality-control based rather than involving known pathogens or acute health risks, placing it in the Moderate category.
Plain-English summary
Perrigo Company PLC is recalling Fexofenadine Hydrochloride tablets, 12-hour formulation, 60mg antihistamine strength, sold in 100-count bottles, manufactured in the Czech Republic and distributed by Perrigo in Michigan. The recall involves 41,472 containers distributed nationwide in the USA.
The recall was initiated because out-of-specification results for impurity A were obtained during stability testing, indicating the product failed to meet established purity standards.
Affected lots are: Lot# 0CR0510 (expiration 09/30/21), 0GR0445 (expiration 01/31/22), 0LR0361 (expiration 04/30/22), and 1AR0558 (expiration 07/31/22). The product identifiers are NDC 45802-425-78 and UPC 3 45802 425 78 2.
Consumers should stop using the recalled product and contact their pharmacist or healthcare provider with questions.
The recalled product
- Product
- Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2
- Manufacturer
- Perrigo Company PLC
- Hazard
- impurity-contamination
- degradation-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 (8)
- Lot# 0CR0510
- Exp 09/30/21
- 0GR0445
- Exp 01/31/22
- 0LR0361
- Exp 04/30/22
- 1AR0558
- Exp 07/31/22
Distribution
Distributed nationwide across the United States.
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