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

FDA recall notice · announced March 26, 2014 · Pfizer Us Pharmaceutical Group

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: G85041
Quantity: 70,704 bottles
Status: Terminated
Products in this recall event:
- Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 (D-1166-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.