D-0628-2024 Class III Terminated
FDA drug recall D-0628-2024 was initiated by Novel Laboratories, Inc. d.b.a Lupin Somerset on July 2, 2024 and is designated Class III. Reason for recall: Defective container: potential for non-sealed pouches which can lead to product leakage. The recall status is terminated (terminated April 28, 2025). Affected quantity: 13,200 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2024
- Initiation Date
- July 2, 2024
- Termination Date
- April 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,200 cartons
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.
Reason for Recall
Defective container: potential for non-sealed pouches which can lead to product leakage.
Distribution Pattern
Nationwide in the US.
Code Information
Lot #S300542, exp. date June 30, 2025