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Recall Observatory FDA recall evidence

Drug 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)

D-1424-2012

April 26, 2012

Class III

Product summary

Firm
Bayer Healthcare, LLC
Event
Event 61948
Status
Terminated
Classification
Class III
Quantity
48,528 cartons
Official record key
drug-enforcement:D-1424-2012

Official wording

Reason: 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.

Code information: NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13

Distribution pattern: Product was distributed to 93 retail accounts/customers.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-up