Skip to content
Back to recalls
Drug FDA Class III Terminated Quality

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.

Novel Laboratories, Inc. d.b.a Lupin Somerset Published Aug 14, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 35/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Novel Laboratories, Inc. d.b.a Lupin Somerset or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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.

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID · 13,200 cartons

NDC: 0093-3560, 0093-3560-19, 0093-3560-26, 0093-9044-19, 0093-9043-19
Lot codes: S300542
Code info: Lot #S300542, exp. date June 30, 2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 2, 2024
  2. Published
    Aug 14, 2024
  3. Terminated
    Apr 28, 2025
Recall number
D-0628-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.