PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 25, 2012 Initiated: April 26, 2012 #D-1423-2012

Product Description

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

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.

Details

Recalling Firm
Bayer Healthcare, LLC
Units Affected
119,412 cartons
Distribution
Product was distributed to 93 retail accounts/customers.
Location
Morristown, NJ

Frequently Asked Questions

What product was recalled?
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24. Recalled by Bayer Healthcare, LLC. Units affected: 119,412 cartons.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 25, 2012. Severity: Low. Recall number: D-1423-2012.