Status
Terminated
Drug Enforcement D-0628-2024
Defective container: potential for non-sealed pouches which can lead to product leakage.
Classification
Class III
Report Date
August 14, 2024
Termination Date
April 28, 2025
Product Information
- 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.
- Product quantity
- 13,200 cartons
- Reason for recall
- Defective container: potential for non-sealed pouches which can lead to product leakage.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US.
Location & Firm
- Recalling firm
- Novel Laboratories, Inc. d.b.a Lupin Somerset
- Address
-
400 Campus Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0628-2024
- Event ID
- 94924
- Recall initiation date
- July 2, 2024
- Center classification date
- August 7, 2024
- Code info
- Lot #S300542, exp. date June 30, 2025
- More code info
- —