FDA recall D-1166-2014

Pfizer Us Pharmaceutical Group · Class III · drug

Product

Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43

Reason for recall

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-02-26
Report date
2014-03-26
Termination date
2015-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1166-2014