D-0628-2024 Class III Terminated

Recalled by Novel Laboratories, Inc. d.b.a Lupin Somerset — Somerset, NJ

Recall Details

Product Type
Drugs
Report Date
August 14, 2024
Initiation Date
July 2, 2024
Termination Date
April 28, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,200 cartons

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.

Distribution Pattern

Nationwide in the US.

Code Information

Lot #S300542, exp. date June 30, 2025