PEG-3350 — Class III drug recall D-0628-2024
Terminated recall by Novel Laboratories, Inc. d.b.a Lupin Somerset, reported 2024-08-14, distributed nationwide. Defective container: potential for non-sealed pouches which can lead to product leakage.
| Recall number | D-0628-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novel Laboratories, Inc. d.b.a Lupin Somerset, Somerset, NJ, United States |
| Recall initiated | 2024-07-02 |
| Classified | 2024-08-07 |
| Reported by FDA | 2024-08-14 |
| Terminated | 2025-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 13,200 cartons |
| Reason classes | packaging |
| NDC | 00093-3560, 00093-3560-19, 00093-3560-26, 00093-9043-19, 00093-9044-19 |
| Lot numbers | S300542 |
| Expiration dates | 2025-06-30 |
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 for recall
Defective container: potential for non-sealed pouches which can lead to product leakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0628-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.