Class III

Drug Recall: 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

Novel Laboratories, Inc. d.b.a Lupin Somerset · July 2, 2024

Reason for Recall

Defective container: potential for non-sealed pouches which can lead to product leakage.

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.

Distribution

Nationwide in the US.

States Affected

NATIONWIDE

Quantity Affected

13,200 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0628-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.