D-0356-2022 Class II Terminated

Recalled by Perrigo Company PLC — Allegan, MI

FDA drug recall D-0356-2022 was initiated by Perrigo Company PLC on July 27, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. The recall status is terminated (terminated November 8, 2022). Affected quantity: 2,784 bottles.

Recall Details

Product Type
Drugs
Report Date
January 12, 2022
Initiation Date
July 27, 2021
Termination Date
November 8, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,784 bottles

Product Description

CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 1DV1855, exp 4/1/2022