drugs Class III Updated 2012-07-25

Bayer Healthcare, LLC recalls Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate,

Recalled 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)

Hazard / Issue

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.

Issued by

FDA

Distribution: Product was distributed to 93 retail accounts/customers.
Lot/Code Info: NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
View official government recall

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