FlaggedRx← Medication recall checkHome
Class III · Lower riskRecall completed

Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #S300542, exp. date June 30, 2025
Where it was soldNationwide in the US.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTeva Pharmaceuticals USA, Inc.
Brand namePEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Generic namePEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Distributed by / forTeva Pharmaceuticals USA, Inc., North Wales, PA 19454
NDC0093-3560-26
Show the full FDA record
Full product labelPEG-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.
Recalling firmNovel Laboratories, Inc. d.b.a Lupin Somerset
DistributionNationwide in the US.
Quantity13,200 cartons
Recall initiated2024-07-02
Report date2024-08-14
Recall completed2025-04-28
Recall numberD-0628-2024
ClassificationClass III
FDA statusTerminated
Origin on fileSomerset NJ United States

Related

Potassium chloride recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.