PlainRecalls
FDA Drug Moderate Class II Terminated

POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0545-2021

Product Description

POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
934 boxes
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66. Recalled by Cardinal Health Inc.. Units affected: 934 boxes.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0545-2021.