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 10…

Recall date

July 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0628-2024

FDA classification

Class III

Brand / firm

Novel Laboratories, Inc. d.b.a Lupin Somerset

Sold / distributed

Nationwide in the US.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.