Recalls / Class III
Class IIID-0628-2024
Product
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.
- Brand name
- 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
- NDC
- 0093-3560
- FDA application
- ANDA090145
- Affected lot / code info
- Lot #S300542, exp. date June 30, 2025
Why it was recalled
Defective container: potential for non-sealed pouches which can lead to product leakage.
Recalling firm
- Firm
- Novel Laboratories, Inc. d.b.a Lupin Somerset
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 13,200 cartons
- Distribution pattern
- Nationwide in the US.
Timeline
- Recall initiated
- 2024-07-02
- FDA classified
- 2024-08-07
- Posted by FDA
- 2024-08-14
- Terminated
- 2025-04-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0628-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.