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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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.

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Eye drops linked to lethal infection urgently recalled: ‘Immediately stop using them’ Story by Luan Trimi • 5h ago

https://www.msn.com/en-us/health/medical/eye-drops-linked-to-lethal-infection-urgently-recalled-immediately-stop-using-them/ar-AA172q9s?ocid=msedgntp&cvid=88bfcd1d0efe477fa737d0492a42abef 

 

MISSISSIPPI PHARMACY PRACTICE REGUALTIONS ...

https://sos.ms.gov › ACProposed

3 days ago — Drug Orders: The pharmacist must receive a written, electronic or verbal order from an authorized prescriber before dispensing any compounded, sterile products.

 

Online pharmacy fined, barred from filling prescriptions for ...

https://iowacapitaldispatch.com › 2023/01/27 › online-...

6 days ago — ... prescription drugs solely on the basis of an Internet questionnaire; ... failing to include on the label for a compounded drug all of the required ...

 

Bulk Drug Substances Currently Under Review - FDA

https://www.fda.gov › animal-drug-compounding › bul...

Bulk Drug Substance (BDS)	Species	Nomination
Acepromazine maleate	dog, cat, horse	FDA‑2018‑N‑4626‑0114
Acetyl‑D‑glucosamine	dog, horse	FDA‑2018‑N‑4626‑0104
Actinomycin D	dog, cat	FDA‑2018‑N‑4626‑0106

View 174 more rows

 

Recent Animal Drug Safety-Related Labeling Changes

The FDA’s Center for Veterinary Medicine has updated its Recent Animal Drug Safety-Related Labeling Changes page to reflect safety-related labeling changes for the following approved animal drug:

• Regumate (altrenogest oral solution), NADA 131-310

 

01/31/2023

01/24/2023

Adept Life Science, LLC

Division of Human and Animal Food Operations East IV

CGMP/Dietary Supplement/Misbranded

 

01/31/2023	01/30/2023	Noble Elements, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/31/2023	01/30/2023	Organic Heirloom Plants	Center for Food Safety and Applied Nutrition (CFSAN)	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/31/2023	01/30/2023	Dr. Green Mom, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/31/2023	12/20/2022	RightEye, LLC	Division of Medical Device and Radiological Health Operations East	Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
01/31/2023	12/27/2022	Urban Electric Power	Division of Pharmaceutical Quality Operations I	CGMP/Drug Products/Adulterated
01/31/2023	01/18/2023	Mohawk Laboratories Division of NCH Corporation	Division of Pharmaceutical Quality Operations II	CGMP/Drug Products/Adulterated
01/31/2023	01/30/2023	Old Tiles Wallpaper, LLC DBA Old Tiles Decor	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/31/2023	01/30/2023	Monkeypox-treatment.com	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
01/31/2023	06/01/2022	S&S Quality Wholesale Inc.	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
01/31/2023	01/27/2023	Shenzhen GreenSound High-Tech Co., LTD d/b/a Vaporlax	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

llegally Sold Monkeypox (Mpox) Products

 

The U.S. Food and Drug Administration (FDA) issued warnings to companies illegally selling products that claim to cure, treat, mitigate, or prevent human monkeypox (mpox) infection. Mpox is a rare disease that is caused by infection with mpox virus. This virus can spread to anyone through close, personal, often skin-to-skin contact. There are no FDA-approved treatments for mpox. These products, which are often sold online, have not been reviewed by the FDA or proven to be safe and effective to treat mpox or other diseases or conditions. These products may be ineffective, unsafe, and could prevent a person from seeking an appropriate diagnosis and treatment from a health care professional.

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