• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

  • Print
  • Share
  • E-mail

Product Detail

Product Description Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.
Recall Number D-744-2014
Classification Class III
Code Info Lot# 10118234 Exp 05/13 Lot# 10120254 Exp 05/13 Lot# 10123513 Exp 08/13 Lot#10125262 Exp 09/13
Product Distributed Qty 2,978,000/2-caplet packages
Reason For Recall Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Event Detail

Event Id 65181
Product Type Drugs
Status Ongoing
Recalling Firm Novartis Consumer Health
City Lincoln
State NE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.