FDA recall D-1877-2019

Preferred Pharmaceuticals, Inc · Class II · drug

Product

Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Product was distributed to 1 physician in Gainesville Florida.

Key facts

Status
Terminated
Initiation date
2019-08-29
Report date
2019-10-02
Termination date
2023-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1877-2019