February 2018 FDA Recall Drug by Kalchem International, Inc.
D-0582-2018 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Kalchem International, Inc. on February 19, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in TX and the recall is currently terminated.

Recall Number: D-0582-2018

Reason for Recall
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Initiated
02-19-2018
Reported
03-14-2018
Quantity
500 gram jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79304
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.
Kalchem International, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-15-2020
Product Description About Product Description
Full technical description of the product.
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05

Batch or Lot Expiration Information

Lot# : 070717-1