Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, N...
FDA Recall #D-1319-2022 — Class II — June 29, 2022
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.
Reason for Recall
CGMP Deviations: products were stored outside the drug label specifications.
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
67 bottles
Distribution
Nationwide in the USA.
Code Information
Part# 11523723404
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated