Miralax
FDA Recall NDC 11523-7341
Latest: Class II · Status: Terminated · Initiated Jun 29, 2022 · 1 enforcement report
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
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
11523-7268-3Miralax
11523-7268-8Miralax
11523-7268-7Miralax
11523-7268-4Miralax
11523-7268-9Miralax
11523-7268-5Miralax
11523-7234-1Miralax
11523-7234-2Miralax
11523-7234-3Miralax
11523-7234-4Miralax
11523-7234-5Miralax
11523-7234-6Miralax
11523-7234-9Miralax
11523-7341-1Miralax
11523-7341-2Miralax
11523-4357-1Miralax
11523-4357-3Miralax
11523-4357-5Miralax
11523-4357-2Miralax
1152372340Miralax
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.
