Class II · Moderate risk
GaviLyteTM - C PEG-3350
Failed Stability Specification; Out of specification for Osmolarity
Peg-3350
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective container: potential for non-sealed pouches which can lead to product leakage.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
0093-3560-26
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid NDC 00093-3560 |
Kit | Teva Pharmaceuticals USA, Inc. | Rx |
- Recalling firm
- Novel Laboratories, Inc. d.b.a Lupin Somerset
- NDC code
- 0093-3560-26
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0628-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Novel Laboratories, Inc. d.b.a Lupin Somerset
All 2024 recalls
Class III · Low risk
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Chemical Contamination
Class III · Low risk
Famotidine for Oral Suspension
Failed Impurity/Degradation Specification; 12-month stability time point
Other packaging defect recalls from 2024
All packaging defect recalls
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution USP
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk
Docusate Sodium 250 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk
Calcium Carbonate Chewable 500 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
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