FDA recall D-0820-2016

Impax Laboratories, Inc. · Class III · drug

Product

Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp. Date

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-03-17
Report date
2016-04-20
Termination date
2016-10-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hayward, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0820-2016