Perrigo Company PLC: Drug Recall

Recall #D-0335-2022 · 07/27/2021

Class II: Risk

Recall Details

Recall Number: D-0335-2022
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: 138,144 containers

Reason for Recall

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

Product Description

CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, Made in Czech Republic

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.