Key Takeaway
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmace by LUPIN SOMERSET was recalled on March 19, 2019. The hazard: Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmace
Description
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19 UPC 343386050192 a) Lemon Flavor Pack net wt. 2 g UPC 343386200023 b) Orange Flavor Pack net wt. 2 g UPC 343386202027 c) Cherry Flavor Pack net wt. 2 g UPC 3433862034
Hazard / Reason
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmace
DrugsCompany Information
LUPIN SOMERSET
Somerset, NJ, United States
View all 13 recalls by LUPIN SOMERSET →Distribution
Nationwide
Related Recalls
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 2
April 10, 2019
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 2
April 10, 2019
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 2
April 10, 2019
Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 ND
April 10, 2019
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD
April 10, 2019
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ
January 15, 2019
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.