FDA recall D-0289-2022

The Harvard Drug Group · Class II · drug

Product

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2021-08-03
Report date: 2021-12-29
Termination date: 2023-07-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0289-2022