Recall: D-1166-2014

Class III - Minor Violations

Class IIIClassification

2014-02-26Initiated

TerminatedStatus

Pfizer Us Pharmaceutical GroupFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.