PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascor… recall
FDA recall D-0628-2024 · initiated Jul 2, 2024
Novel Laboratories, Inc. d.b.a Lupin Somerset recalled PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate,… in Jul 2024 — an FDA Class III recall (D-0628-2024) because Defective container: potential for non-sealed pouches which can lead to product leakage.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Defective container: potential for non-sealed pouches which can lead to product leakage.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13,200 cartons
Details
- 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.
- Recalling company
- Novel Laboratories, Inc. d.b.a Lupin Somerset
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US.
- Initiated
- Jul 2, 2024
- FDA report date
- Aug 14, 2024
Frequently asked
- Was PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate,… recalled?
- Novel Laboratories, Inc. d.b.a Lupin Somerset recalled PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate,… in Jul 2024 — an FDA Class III recall (D-0628-2024) because Defective container: potential for non-sealed pouches which can lead to product leakage. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate,… recalled?
- Per the FDA enforcement record, the reason for recall D-0628-2024 was: Defective container: potential for non-sealed pouches which can lead to product leakage.
- Is a recalled PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate,… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate,… are affected?
- Distributed: Nationwide in the US.. The recall covers these lots — Lot #S300542, exp. date June 30, 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0628-2024.