FDA Enforcement Class II Terminated

Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)

Recall: Z-1249-2017 · Reported March 1, 2017

Enforcement

Recall Number
Z-1249-2017
Event ID
75829
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Reckitt Benckiser LLC
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date
March 1, 2017
Initiation Date
November 22, 2016
Classification Date
February 23, 2017
Termination Date
January 15, 2020
Address
399 Interpace Pkwy, N/A, Parsippany, NJ, 07054-1133, United States

Description

Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)

Reason

Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.

Code Info

3ct - item code 02340-30042-04 lot code exp date 3 ct - Walmart item code 02340-70042-04 lot code exp date 12ct - item code 02340-30274-08 lot code exp date 24 ct - item code 02340-302190-04 lot codes and exp date

Distribution

Nationwide and Foreign

Quantity

108342 units