Novel Laboratories, Inc. d.b.a Lupin Somerset: Drug Recall
Recall #D-0628-2024 · 07/02/2024
Class III: Low Risk
Recall Details
- Recall Number
- D-0628-2024
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Novel Laboratories, Inc. d.b.a Lupin Somerset
- Status
- Terminated
- Date Initiated
- 07/02/2024
- Location
- Somerset, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,200 cartons
Reason for Recall
Defective container: potential for non-sealed pouches which can lead to product leakage.
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.
Distribution Pattern
Nationwide in the US.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.