FDA recall D-216-2013

L. Perrigo Co. · Class III · drug

Product

PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716

Reason for recall

Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.

Distribution

Walmart Distribution Center in Bentonville, AR

Key facts

Status: Terminated
Initiation date: 2013-02-18
Report date: 2013-04-03
Termination date: 2013-09-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-216-2013