February 2018 FDA Recall Drug by Webrx Dba Rxpalace.com
D-0421-2018 - CGMP Deviations

This Class III drug recall was voluntarily initiated by Webrx Dba Rxpalace.com on February 7, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NY and the recall is currently terminated.

Recall Number: D-0421-2018

Reason for Recall
CGMP Deviations: not manufactured according to current good manufacturing practices.
Initiated
02-07-2018
Reported
02-21-2018
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79172
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Webrx dba RxPalace.com
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2020
Product Description About Product Description
Full technical description of the product.
BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74

Batch or Lot Expiration Information

Lot# Lot: 17JXIII, Exp. 12/31/2019