Colonoscopy Prep Kits Recalled

Novel Laboratories Inc., which does business as Lupin Somerset, is recalling 13 200 cartons of colonoscopy preparation kits containing PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution. According to the August 14, 2024, US Food and Drug Administration (FDA) Enforcement Report, there is a potential for unsealed pouches that can lead to product leakage.

The recall affects PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution, 3 pouches per carton (NDC 0093-3560-26), from lot S300542 (Exp. 6/30/25). The kits were distributed throughout the United States by Teva Pharmaceuticals USA Inc., North Wales, Pennsylvania.

Novel Laboratories voluntarily initiated the recall on July 2, 2024. On August 7, 2024, the FDA designated the recall Class III, signaling that use of the affected product is not likely to cause harm.

PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution is an osmotic laxative available with a prescription for cleansing the colon as preparation for colonoscopy in adults.