Key Takeaway

Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 6201 by Perrigo Company PLC was recalled on July 27, 2021. The hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

FDA Drug Class II Terminated

Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 6201

Recalled: July 27, 2021 ~12,384 containers units affected D-0337-2022

Description

Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 6201

Drugs

Company Information

Perrigo Company PLC

Allegan, MI, United States

View all 106 recalls by Perrigo Company PLC →

Distribution

Nationwide in the USA

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