April 2022 FDA Recall Gavilyte - C by Lupin Pharmaceuticals Inc.
D-0875-2022 - Failed Stability Specification

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on April 27, 2022 for the product Gavilyte - C. The FDA reported the reason for recall as failed stability specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0875-2022

Reason for Recall
Failed Stability Specification
Initiated
04-27-2022
Reported
05-25-2022
Quantity
26,910 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90094
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
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

43386-060-19 Gavilyte - C Tm