FDA recall D-0332-2022

Product

basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 2

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-07-27

Report date

2022-01-12

Termination date

2022-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0332-2022