Novel Laboratories, Inc. d.b.a Lupin Somerset recalls PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100
Recalled August 14, 2024 · FDA recall D-0628-2024 · Novel Laboratories, Inc. d.b.a Lupin Somerset
Hazard
Defective container: potential for non-sealed pouches which can lead to product leakage. · FDA Class III
Units
13,200 cartons
Sold at
Nationwide in the US.
Description
Defective container: potential for non-sealed pouches which can lead to product leakage.
Product
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.
Manufacturer(s)
Novel Laboratories, Inc. d.b.a Lupin Somerset
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →