FDA recall D-1319-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

Product

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.

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2022-06-29
Report date: 2022-08-17
Termination date: 2024-02-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

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