FDA Drug recall D-0628-2024
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.…
- FDA Drug
- Class III
- terminated
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class III recall of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.… by Novel Laboratories D B A Lupin Somerset, citing defective container: potential for non-sealed pouches which can lead to product leakage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0628-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-07-02 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novel Laboratories D B A Lupin Somerset |
| Distribution | US |
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.
Reason
Defective container: potential for non-sealed pouches which can lead to product leakage.
Identifiers
| ndc | 0093-3560-19 |
|---|---|
| ndc | 0093-3560-26 |
| ndc | 0093-9044-19 |
| ndc | 0093-9043-19 |
| code_info | Lot #S300542, exp. date June 30, 2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0628-2024%22
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