Miralax Powder, For Solution
FDA Recall NDC 11523-7341
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 Miralax (NDC 11523-7341). A significant event, classified as Class II, was initiated on Jun 29, 2022 by Bayer Healthcare Llc.. The reported reason for this action was: "CGMP Deviations: products were stored outside the drug label specifications."
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 II Terminated
CGMP Deviations: products were stored outside the drug label specifications.
Jun 29, 2022
Aug 17, 2022
67 bottles
Recall Profile & Regulatory Data
Event ID
90553
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Feb 13, 2024
Product Description
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.
Batch or Lot Expiration Information
Lot# Part# 11523723404
Affected Packages Involved in this Recall
11523-7268-3Product
11523-7268-8Product
11523-7268-7Product
11523-7268-4Product
11523-7268-9Product
11523-7268-5Product
11523-7234-1Product
11523-7234-2Product
11523-7234-3Product
11523-7234-4Product
11523-7234-5Product
11523-7234-6Product
11523-7234-9Product
11523-7341-1Product
11523-7341-2Product
11523-4357-1Product
11523-4357-3Product
11523-4357-5Product
11523-4357-2Product
1152372340Product
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.
