Recall Z-1382-2021 ยท EAX Mirror, Mouth
Sunstar Americas, Inc.
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
| Date | Mar 23, 2021 |
| Status | Terminated |
| Reason | Product may be contaminated with Burkholderia contaminans. |
| Root cause | Process control |
| Action | Sunstar initiated the recall by letter and email on 03/23/2021. The letter requested the consignee check their inventory and isolate affected product, then contact customer service with the results. The firm requested the return of the product. Distributors are asked to notify their customers down to the user level. |
| Quantity | 19471 bottles |
| Distribution | US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.