FDAHealthJuly 2, 2024
Novel Laboratories, Inc. d.b.a Lupin Somerset — 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
⚠️ Defective container: potential for non-sealed pouches which can lead to product leakage.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 2, 2024
Nationwide in the US.
What's affected?
- 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.
- Brand
- PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
- Lot code
- 300542
Additional details
Lot #S300542, exp. date June 30, 2025
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 13,200 cartons.
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