Recall: D-0628-2024

Class III - Minor Violations

Class IIIClassification

2024-07-02Initiated

TerminatedStatus

Novel Laboratories, Inc. d.b.aFirm

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.

Distribution

Nationwide in the US.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.