Bayer Healthcare, LLC: 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,

Is my product affected?

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)

• Brand MIDOL COMPLETE

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

What happened

Bayer Healthcare is recalling Midol Complete caplets in 16-count and 24-count blister packages due to a labeling mismatch. The label on the blister strip and the label on the carton contain different statements about the maximum number of caplets that should be taken in a 24-hour period. The affected product was distributed to 93 retail accounts, totaling 48,528 cartons with lot codes NAA055N, NAA05PC, and NAA0462, all expiring in December 2013.

The source document does not specify a remedy or instructions for what consumers should do regarding 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: 48,528 cartons Lot/code info: NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13

Source

Official record: FDA (Drug enforcement) ↗

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

Related recalls

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All FDA (Drug enforcement) recalls