FDA-Drug2022-08-17Class II

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.

Mckesson Medical-Surgical Inc. Corporate Office
Hazard

CGMP Deviations: products were stored outside the drug label specifications.

Sold states
Nationwide in the USA.
Affected count
67 bottles
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1319-2022

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