Gavilyte - C Powder, For Solution
FDA Recall NDC 43386-060
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Gavilyte - C (NDC 43386-060). A significant event, classified as Class II, was initiated on Apr 27, 2022 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Failed Stability Specification"
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
Class II Terminated
Failed Stability Specification
Apr 27, 2022
May 25, 2022
26,910 bottles
Recall Profile & Regulatory Data
Event ID
90094
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide, including Puerto Rico.
Termination Date
Apr 13, 2023
Product Description
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Batch or Lot Expiration Information
Lot# S001132, exp. date July 2022 NDC # 43386-060-19
Affected Packages Involved in this Recall
43386-060-19Product
July 2021 Class II Recall: Failed Stability Specification; Out of specification for Osmolarity
Recall Number
Class II Terminated
Failed Stability Specification; Out of specification for Osmolarity
Jul 29, 2021
Aug 25, 2021
20,814 bottles
Recall Profile & Regulatory Data
Event ID
88390
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Novel Laboratories, Inc. d.b.a LUPIN
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 14, 2022
Product Description
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19
Batch or Lot Expiration Information
Lot# Lot S001133, exp 7/2022
Affected Packages Involved in this Recall
43386-060-19Product
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.
