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
Reported: April 17, 2019 Initiated: March 19, 2019 #D-1113-2019
Product 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
Reason for Recall
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Details
- Recalling Firm
- LUPIN SOMERSET
- Units Affected
- 76422 bottles
- Distribution
- Nationwide
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by LUPIN SOMERSET. Units affected: 76422 bottles.
Why was this product recalled? ▼
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2019. Severity: Moderate. Recall number: D-1113-2019.
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