FDA recall D-0628-2024

Novel Laboratories, Inc. d.b.a Lupin Somerset · Class III · drug

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.

Distribution

Nationwide in the US.

Key facts

Status: Terminated
Initiation date: 2024-07-02
Report date: 2024-08-14
Termination date: 2025-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2024