Home / Recalls / Pfizer Us Pharmaceutical Group / D-1166-2014

D-1166-2014 Class III Terminated

Recalled by Pfizer Us Pharmaceutical Group — New York, NY

Recall Details

Product Type
Drugs
Report Date
March 26, 2014
Initiation Date
February 26, 2014
Termination Date
July 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70,704 bottles

Product Description

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 Pattern

Nationwide

Code Information

G85041

Other recalls by Pfizer Us Pharmaceutical Group

  • D-1409-2014 Class II — Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx onl (April 16, 2014)
  • D-1328-2014 Class I — Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 3 (March 6, 2014)
  • D-014-2014 Class II — Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Dis (September 4, 2013)