TopCare Allergy Relief Fexofenadine tablets recalled for impurity specification failure
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 60mg tablets (12-count bottles, Lot #0LE2178) distributed nationwide due to an out-of-specification impurity result found during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 specification failure. No illnesses or injuries are reported in the source text, and the hazard is the presence of an unspecified impurity identified during routine stability testing—a quality control matter without reported patient harm.
Plain-English summary
Perrigo Company PLC is recalling TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine (12-count bottles, NDC 36800-954-53) distributed nationwide in the USA. The recall was initiated because stability testing revealed an out-of-specification result for impurity A, indicating the product does not meet required purity specifications.
The affected product lot is #0LE2178 with an expiration date of 01/31/2022, comprising 26,304 containers. The product was manufactured in the Czech Republic and distributed by Topco Associates LC, Elk Grove Village, IL 60007.
Consumers with this product should stop using it and consult their healthcare provider with any questions. For more information, consumers can contact the manufacturer or the FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.
The recalled product
- Product
- TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
- Manufacturer
- Perrigo Company PLC
- Affected units
- 26,304
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 # 0LE2178
- Exp 01/31/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Perrigo Company PLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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