- Source
- FDA Enforcement Report
- Date
- Jan 12, 2022 (FDA report date)
- Filed by
- Perrigo Company PLC, Allegan, MI
- Quantity
- 42,026 containers (FDA, Jan 12, 2022)
- Class
- Class II
- Status
- Terminated (when we checked)
- Reason
- Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- Label text
- KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, UPC 0 96619 98776 4
Who makes Kirkland Signature Aller-Fex 24-Hour Allergy (fexofenadine 180 mg)?
Allegan, MI · packager · as of Jan 12, 2022
Sold by Costco under its Kirkland Signature label.
The label text in the record reads "Made in the Czech Republic" and "Packaged by Perrigo" for Costco Wholesale.
The record
Date checked: 2026-10-31. A record shows who made or recalled the product at that time. It does not prove who makes it today, and we never say a store-brand item is “the same” as a name brand unless a record says so.
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