Gavilyte-n Powder, For Solution
FDA Recall NDC 43386-050
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Gavilyte-n (NDC 43386-050). A significant event, classified as Class II, was initiated on Mar 19, 2019 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2019 Class II Recall: Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Recall Number
Class II Terminated
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Mar 19, 2019
Apr 17, 2019
76422 bottles
Recall Profile & Regulatory Data
Event ID
82396
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 23, 2022
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
Batch or Lot Expiration Information
Lot# : a) S800021, Exp 30-Nov-20; b) S800175, Exp 31-Dec-20; c) S 800401, Exp 28-Feb-21; S800426, Exp 31-Mar-21; S800920, Exp 31-Aug-21.
Affected Packages Involved in this Recall
43386-050-19Product
3433860501Product
3433862000Product
3433862020Product
3433862034Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
