Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot #S300542, exp. date June 30, 2025
Where it was sold
Nationwide in the US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0628-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 2, 2024
- FDA report date
- Aug 14, 2024
- Quantity
- 13,200 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novel Laboratories, Inc. d.b.a Lupin Somerset
Original FDA data
Every field from FDA enforcement report D-0628-2024, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 94924
- Address
- 400 Campus Dr
- Code information
- Lot #S300542, exp. date June 30, 2025
- Postal code
- 08873-1145
- Report date
- Aug 14, 2024
- Product type
- Drugs
- Recall number
- D-0628-2024
- Classification
- Class III
- Recalling firm
- Novel Laboratories, Inc. d.b.a Lupin Somerset
- Product quantity
- 13,200 cartons
- Termination date
- Apr 28, 2025
- Reason for recall
- Defective container: potential for non-sealed pouches which can lead to product leakage.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Jul 2, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2024