Perrigo Company PLC: Drug Recall

Recall #D-0355-2022 · 07/27/2021

Class II: Risk

Recall Details

Recall Number: D-0355-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Perrigo Company PLC
Status: Terminated
Date Initiated: 07/27/2021
Location: Allegan, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 42,026 containers

Reason for Recall

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Product Description

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Perrigo Company PLC

Class II: Risk 10/26/2021

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II: Risk 10/26/2021

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II: Risk 10/26/2021

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II: Risk 10/26/2021

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II: Risk 10/26/2021

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

View all recalls by Perrigo Company PLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.