Reported Aug 14, 2024 · Terminated

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution…

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

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Novel Laboratories, Inc. d.b.a Lupin Somerset · 400 Campus Dr · Somerset, NJ · 08873-1145

Is this the product you have?

  • 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 byTeva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26
Lot codes and dates
    • Lot #S300542
    • exp. date June 30
    • 2025
Amount recalled
13,200 cartons

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 28, 2025 · Data as of Sep 19, 5:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.