Advil Pm Tablet, Coated
FDA Recall NDC 0573-0164
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Advil Pm (NDC 0573-0164). A significant event, classified as Class III, was initiated on Feb 26, 2014 by Haleon Us Holdings Llc. The reported reason for this action was: "Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Feb 26, 2014
Mar 26, 2014
70,704 bottles
Recall Profile & Regulatory Data
Event ID
67617
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Us Pharmaceutical Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 10, 2015
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
Batch or Lot Expiration Information
Lot# G85041
Affected Packages Involved in this Recall
0573-0164-33Product
0573-0164-04Product
0573-0164-20Product
0573-0164-30Product
0573-0164-40Product
0573-0164-43Product
0573-0164-45Product
0573-0164-32Product
0573-0164-41Product
0573-0164-91Product
0573-0164-05Product
0573-0164-55Product
0573-0164-21Product
0573-0164-44Product
0573-0164-14Product
0573-0164-12Product
0573-0164-49Product
0573-0164-46Product
0573-0164-65Product
0573-0164-08Product
0573-0164-09Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
