Midol Complete Tablet
FDA Recall NDC 0280-8005
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Midol Complete (NDC 0280-8005). A significant event, classified as Class III, was initiated on Apr 26, 2012 by Bayer Healthcare Llc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
Apr 26, 2012
Jul 25, 2012
48,528 cartons
Recall Profile & Regulatory Data
Event ID
61948
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Bayer Healthcare, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 93 retail accounts/customers.
Termination Date
Mar 27, 2014
Product Description
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)
Batch or Lot Expiration Information
Lot# NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13
Affected Packages Involved in this Recall
0280-8005-16Product
0280-8005-24Product
0280-8005-40Product
0280-8005-01Product
0280-8005-02Product
0280-8005-04Product
0280-8005-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
