Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid Kit
FDA Recall NDC 0093-3560
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid (NDC 0093-3560). A significant event, classified as Class III, was initiated on Jul 02, 2024 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Defective container: potential for non-sealed pouches which can lead to product leakage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Defective container: potential for non-sealed pouches which can lead to product leakage.
Jul 02, 2024
Aug 14, 2024
13,200 cartons
Recall Profile & Regulatory Data
Event ID
94924
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Novel Laboratories, Inc. d.b.a Lupin Somerset
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US.
Termination Date
Apr 28, 2025
Product Description
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.
Batch or Lot Expiration Information
Lot# S300542, exp. date June 30, 2025
Affected Packages Involved in this Recall
0093-3560-19Product
0093-3560-26Product
0093-9044-19Product
0093-9043-19Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
