PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Aci...
FDA Recall #D-0628-2024 — Class III — July 2, 2024
Product Description
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.
Reason for Recall
Defective container: potential for non-sealed pouches which can lead to product leakage.
Recalling Firm
Novel Laboratories, Inc. d.b.a Lupin Somerset — Somerset, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
13,200 cartons
Distribution
Nationwide in the US.
Code Information
Lot #S300542, exp. date June 30, 2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated