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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716
Recall Number D-216-2013
Classification Class III
Code Info 2 AE1549 Exp. 02/13
Product Distributed Qty 60,048 Blister packs
Reason For Recall Failed Stability Specifications: The product had a stability failure at the 12 month time point for the active ingredient Phenylephrine HCL.

Event Detail

Event Id 64388
Product Type Drugs
Status Ongoing
Recalling Firm L. Perrigo Co.
City Allegan
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Walmart Distribution Center in Bentonville, AR