FDAFDA · Food and drugs·Recall number D-0545-2021
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
Published June 2, 2021 · Recall initiated: March 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- POLYETHYLENE GLYCOL 3350
- Manufacturer
- Cardinal Health Inc.
- Distributor
- FL, GA, SC
- Lot
- All Lots distributed 02/23/2021 through 03/10/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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