February 2014 FDA Recall Advil Pm by Pfizer Us Pharmaceutical Group
D-1166-2014 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Pfizer Us Pharmaceutical Group on February 26, 2014 for the product Advil Pm. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1166-2014
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
02-26-2014
03-26-2014
70,704 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Us Pharmaceutical Group
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-10-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# G85041
