Recall D-0628-2024
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.
Recall D-0628-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0628-2024 |
| Event ID | 94924 |
| Brand | PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID |
| Generic Name | PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID |
| Manufacturer | PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID |
| Original Package? | 1 |
| Distribution | Nationwide in the US. |
| Quantity | 13,200 cartons |
| Recall Reason | Defective container: potential for non-sealed pouches which can lead to product leakage. |
| Drug Classification | Class III |
| Drug Code Info | 20240814 |
| Product NDC | 0093-3560 |
| Recall Initiation Date | 20240702 |
| Report Date | 20240814 |
| Classification Date | 20240807 |
| Address | 400 Campus Dr Somerset, NJ 08873-1145 United States |
| Recalling Firm | Novel Laboratories, Inc. d.b.a Lupin Somerset |
| Initial Notification | Letter |
| Drug Application Number | ANDA090145 |
| Structured Product Labeling (SPL ID) | 46e37694-3149-46b3-a949-fad3ccbb8052 |
| Structured Product Labeling (SPL Set ID) | 475a06c6-f295-406c-a110-f1497cf51566 |
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