BUTLER Clear Dip, 12 bottles/case
FDA Recall Z-0720-2022 · Posted None
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Recalling FirmSunstar Americas, Inc.
Recall StatusTerminated
Product CodeOCT
Date Initiated2022-01-14
Date Terminated2023-08-28
Product Quantity22514 ea
Reason for Recall
Product lacks premarket clearance.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
United States Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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