Product: "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***SPANISH NEEDLE***1oz.***USES: HEART AILMENTS, DIABETES, LOWERS FEVER***"; packaged in clear plastic zip-top bags
Reason for recall: Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Recall initiated: 20200630
Status: Terminated
Classification: Class II
Recall type: FDA Mandated