Somerset, NJ, United States
Novel Laboratories, Inc. d.b.a Lupin Somerset recalls
1 recall recorded since 2018, most recently on 2 July 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 2 July 2024
- Terminated
- 28 April 2025
- Reason
- Defective container: potential for non-sealed pouches which can lead to product leakage.
- Distribution
- Nationwide in the US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuti
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.