Drug recall D-1424-2012

Class III Terminated reported Jul 25, 2012

Product

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)

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.

Lots and codes

NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13

Recall details

Recalling firm
Bayer Healthcare, LLC, Morristown, NJ
Quantity
48,528 cartons
Distribution
Product was distributed to 93 retail accounts/customers.
Type
Voluntary: Firm initiated
Recall initiated
April 26, 2012
Terminated
March 27, 2014

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