Perrigo Company PLC: Drug Recall

Recall #D-0328-2022 · 07/27/2021

Class II: Risk

Recall Details

Recall Number: D-0328-2022
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: 55,032 units

Reason for Recall

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

Product Description

EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.

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.