Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, February 9, 2023
Wednesday, February 8, 2023
Opinion: Poodle's death after vet visit shows why Texas Vet Board needs revamp - The Dallas Morning News
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| Salon Technologies International, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Mark S. Denker, M.D., PA dba Palm Beach Fertility Center | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | ||||
| Quality Supplement Manufacturing, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | ||||
| MicroVention Costa Rica S.R.L. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | ||||
| Getsch+Hiller Medizintechnik GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | ||||
| J.M. Smucker LLC | Division of Human and Animal Food Operations East V | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | ||||
| AMO and Wing Inc. dba T and H Trading Co. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| HST Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| The Body Bean, LLC | Center for Drug Evaluation and Research | CDER | Failure to Register and List |
PrimeZen Black 6000 contains hidden drug ingredients
FDA is notifying consumers of a product promoted for sexual enhancement that has been found to contain hidden ingredients and might pose a significant health risk: PrimeZen Black 6000 contains hidden drug ingredients. FDA laboratory analysis confirmed that PrimeZen Black 6000 contains sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approvals of Viagra and Cialis are restricted to use under the supervision of a licensed health care professional. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.
FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.
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Friday, February 3, 2023
MANNERS Energy Boost contains hidden drug ingredient
FDA is notifying consumers of a product promoted to boost energy that has been found to contain a drug hidden ingredient and might pose a significant health risk. MANNERS Energy Boost contains tadalafil, the active ingredient in the FDA-approved prescription drug Cialis, used to treat erectile dysfunction. Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.
FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.