FDA-Drug2024-08-14Class III
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.
Novel Laboratories, Inc. d.b.a Lupin Somerset
Hazard
Defective container: potential for non-sealed pouches which can lead to product leakage.
Sold states
Nationwide in the US.
Affected count
13,200 cartons
Manufactured in
400 Campus Dr, Somerset, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2024Don't want to check this manually?
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