FDAFDA · Food and drugs·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 Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.
Published August 14, 2024 · Recall initiated: July 2, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective container: potential for non-sealed pouches which can lead to product leakage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
- Manufacturer
- Novel Laboratories, Inc. d.b.a Lupin Somerset
- Distributor
- Nationwide in the US.
- Lot
- Lot #S300542, exp. date June 30, 2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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