FDA Recall Terminated

BUTLER Clear Dip, 12 bottles/case

Recall: Z-0720-2022 · Initiated January 14, 2022

Recall

Recall Number
Z-0720-2022
Event Number
89460
Firm
Sunstar Americas, Inc.
FEI Number
1413787
Product Code
OCT
Status
Terminated
Root Cause
No Marketing Application
Initiated
January 14, 2022
Terminated
August 28, 2023
Address
301 E Central Rd, Schaumburg, IL, 60195-1901

Description

BUTLER Clear Dip, 12 bottles/case

Reason

Product lacks premarket clearance.

Action

A Recall Letter is being sent to all direct consignees who have received impacted product via USPS First Class mail The Recall Letter will be posted to the corporate web site at www.gumbrand.com Customers are instructed as follows: 1. Please examine your inventory to determine if you have any of the affected product lots 2. Please call 1-800-528-8537 or email: [email protected] with the results of your inventory check (even if the affected lots are no longer in inventory), and if affected lots are present, provide the lot numbers, quantities, and a recall contact. 3. Complete the enclosed Return Response Form and mail, FAX or email the completed form as per the instructions provided. 4. The recalling firm will issue a call tag via UPS for any affected inventory to be returned 5. Upon receipt of the call tag return any affected products to the recalling firm 6. Because this recall is being initiated to the dental office level, the recalling firm asks that consignees also notify any parties to which you have further distributed the product.

Distribution

United States Nationwide distribution.

Quantity

22514 ea