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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25)
Recall Number D-1424-2012
Classification Class III
Code Info NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
Product Distributed Qty 48,528 cartons
Reason For Recall Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

Event Detail

Event Id 61948
Product Type Drugs
Status Ongoing
Recalling Firm Bayer Healthcare, LLC
City Morristown
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Product was distributed to 93 retail accounts/customers.