BUTLER Clear Dip, 12 bottles/case
This recall has been terminated (originally issued January 14, 2022).
- Company
- Sunstar Americas, Inc.
- Recall Initiated
- January 14, 2022
- Terminated
- August 28, 2023
- Recall Number
- Z-0720-2022
- Quantity
- 22514 ea
- Firm Location
- Schaumburg, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Product lacks premarket clearance.
Distribution
United States Nationwide distribution.
Lot / Code Info
SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD
Root Cause
No Marketing Application
Action Taken
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: us.pcr@us.sunstar.com 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.