Date Initiated by Firm |
November 22, 2016 |
Create Date |
February 23, 2017 |
Recall Status1 |
Terminated 3 on January 15, 2020 |
Recall Number |
Z-1249-2017 |
Recall Event ID |
75829 |
Product Classification |
Condom - Product Code HIS
|
Product |
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)
|
Code Information |
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 |
Recalling Firm/ Manufacturer |
Reckitt Benckiser LLC 399 Interpace Pkwy Parsippany NJ 07054-1133
|
For Additional Information Contact |
Stericycle Expert Solutions 877-830-9730
|
Manufacturer Reason for Recall |
Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
|
FDA Determined Cause 2 |
Error in labeling |
Action |
Reckitt Benckiser LLC sent an Urgent Medical Device Recall letter/business response form dated November 22, 2016 to the affected customers. Stericylcle is handling returns. |
Quantity in Commerce |
108342 units |
Distribution |
Nationwide and Foreign |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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