The Food and Drug Administration is advising consumers not to purchase or use Primal Herbs Volume, a product promoted and sold for sexual enhancement on various websites, including primalherbs.com, and possibly in some retail stores.
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This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.Pediatrics and Maternal Health
DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related information in product labeling.FDA Publishes Filing Checklists to Prevent Submission Delays
The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable.KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged
Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distribAgebox Inc. – 718252 – 12/19/2025
Unapproved New Drug/Misbranded