PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100
Summary
The FDA issued a Class III for PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, by Novel Laboratories, Inc. d.b.a Lupin Somerset. Reason: Defective container: potential for non-sealed pouches which can lead to product leakage..
Details
Source
Drug Recall
External ID
D-0628-2024
Action Date
2024-08-14
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot #S300542, exp. date June 30, 2025
Quantity Affected: 13,200 cartons
Reason for Recall
Defective container: potential for non-sealed pouches which can lead to product leakage.
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-02
Company
Somerset, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novel Laboratories, Inc. d.b.a Lupin Somerset) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novel Laboratories, Inc. d.b.a Lupin Somerset have FDA actions?
This is the only FDA action we have on record for Novel Laboratories, Inc. d.b.a Lupin Somerset in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0628-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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