FDA-Drug2012-07-25Class III

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24

Bayer Healthcare, LLC
Hazard

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.

Sold states
Product was distributed to 93 retail accounts/customers.
Affected count
119,412 cartons
Manufactured in
36 Columbia Rd, Morristown, NJ, United States
Products
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1423-2012

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