Recalling firm
Novel Laboratories, Inc. d.b.a Lupin Somerset
Product type
Drug
Status
Terminated
Report date
2024-08-14
Distribution
Nationwide in the US.
Firm state
NJ
Product quantity
13,200 cartons
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective container: potential for non-sealed pouches which can lead to product leakage.
Product description
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.
Code / lot info
Lot #S300542, exp. date June 30, 2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.