PlainRecalls
FDA Drug Moderate Class II Terminated

H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9

Reported: January 12, 2022 Initiated: July 27, 2021 #D-0339-2022

Product Description

H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9

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
26,304 containers
Distribution
Nationwide in the USA
Location
Allegan, MI

Frequently Asked Questions

What product was recalled?
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9. Recalled by Perrigo Company PLC. Units affected: 26,304 containers.
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-0339-2022.