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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, 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
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
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