Novel Laboratories, Inc. d.b.a Lupin Somerset is recalling 13,200 cartons of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution. This prescription medication, which is used to clear the bowels before medical procedures, was found to have a packaging defect where some pouches may not be properly sealed. This defect can lead to the product leaking out of its container. If you have health concerns regarding this product, you should contact your doctor or pharmacist.
The unsealed pouches allow the oral solution powder to leak out of the packaging, which could compromise the product's sterile integrity or lead to an incorrect dosage.
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Distributed by Teva Pharmaceuticals USA, Inc.
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Sources: FDA iRES · Raw API Response
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