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

Is my product affected?

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

• Brand MIDOL COMPLETE

Check against the official notice below — it lists the full affected range.

What happened

Bayer Healthcare has recalled Midol Complete gelcaps in 24-count blister packs due to a labeling discrepancy. The label on the blister strip and the label on the carton contain conflicting information about the maximum number of capsules that should be taken within a 24-hour period. The affected product was distributed to 93 retail accounts, totaling 119,412 cartons, with lot codes NAA04K6, NAA055P, and NAA05PA, all expiring in September 2013.

The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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. Distribution: Product was distributed to 93 retail accounts/customers. Quantity: 119,412 cartons Lot/code info: NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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)2012-04-26
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All FDA (Drug enforcement) recalls