FDA Drug Recalls

Recalls / Active ingredient / Polyethylene Glycol 3350

Polyethylene Glycol 3350

6 FDA drug recalls involving the active ingredient “Polyethylene Glycol 3350.

DateClassProductFirm
2022-06-29Class IIMiralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZMckesson Medical-Surgical Inc. Corporate Office
2022-04-27Class IIGaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 4Lupin Pharmaceuticals Inc.
2021-07-29Class IIGaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Novel Laboratories, Inc. d.b.a LUPIN
2021-03-15Class IIPOLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (Cardinal Health Inc.
2021-03-15Class IIPolyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-Cardinal Health Inc.
2019-03-19Class IIGavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, MLUPIN SOMERSET