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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13 Class III 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. 119,412 cartons D-1423-2012
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) NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13 Class III 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. 48,528 cartons D-1424-2012
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