PlainRecalls
FDA Drug Moderate Class II Terminated

amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2

Reported: January 12, 2022 Initiated: July 27, 2021 #D-0354-2022

Product Description

amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2

Reason for Recall

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

Details

Recalling Firm
Perrigo Company PLC
Units Affected
38,352 bottles
Distribution
Nationwide in the USA
Location
Allegan, MI

Frequently Asked Questions

What product was recalled?
amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2. Recalled by Perrigo Company PLC. Units affected: 38,352 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 12, 2022. Severity: Moderate. Recall number: D-0354-2022.