05/03/2022	04/22/2022	Crystal Canyon Vapes LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
05/02/2022	05/02/2022	Breathe Easy Vapes, LP dba Breathe Easy Vapes	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

 

05/03/2022	03/28/2022	Madras Groceries	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
05/03/2022	02/24/2022	MYA International, Inc.	Office of Human and Animal Food Operations –West Division 5	Unapproved New Drugs/Misbranded
05/03/2022	04/14/2022	SCO Koladen LLC	West Coast Import District Compliance Branch - Team 2 (WCID-CB)	Foreign Supplier Verification Program (FSVP)
05/03/2022	04/14/2022	Froggy’s Fog LLC	Office of Pharmaceutical Quality Operations, Division II	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
05/03/2022	04/20/2022	C R Supplements, LLC	Office of Human and Animal Food Operations – West Division 6	Unapproved New Drugs/Misbranded
05/03/2022	02/11/2022	Rena's Organic	Office of Human and Animal Foods Division 4 East	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/03/2022	02/16/2022	Best Fiji Kava, Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
05/03/2022	04/20/2022	Miami University Department of Chemistry and Biochemistry	Pharmaceutical Quality Operations Division III	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
05/03/2022	03/11/2022	Don’t Run Out dba Public Goods	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
05/03/2022	04/26/2022	Cigsweb.com	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

 

05/04/2022	05/04/2022	Kingdom Harvest	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022	05/04/2022	Delta 8 Hemp	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022	05/04/2022	ATLRx, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022	05/04/2022	BioMD Plus LLC	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/04/2022	05/04/2022	M Six Labs, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
05/03/2022	05/03/2022	Lynda’s Legacy LLC d/b/a Chaney’s Tobacco Station	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
05/03/2022	04/18/2022	Age Management Institute Santa Barbara	Division of Pharmaceutical Quality Operations IV	Compounding Pharmacy/Adulterated Drug Products
05/03/2022	04/07/2022	Global Imports Inc.	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
05/03/2022	03/28/2022	Bhan Kanom Thai Inc	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
05/03/2022	04/12/2022	The W.S. Badger Company, Inc.	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated

FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

 Today, the U.S. Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products.

There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.

Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.

The FDA recently published a consumer update expressing serious concerns about the potential health effects of delta-8 THC products. The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners, and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment. The agency is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.

Learn More

 

04/26/2022	04/22/2022	Vape Junkie EJuice	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/26/2022	04/13/2022	7333 LLC	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
04/26/2022	03/17/2022	Vitae Enim Vitae Scientific Inc.	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
04/26/2022	04/15/2022	White Horse Vapor Store, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/26/2022	04/14/2022	Cetylite Industries, Inc.	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated
04/26/2022	03/01/2022	Clinical Resolution Laboratory Inc.	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
04/26/2022	04/19/2022	Guangzhou Zhongkebaishi Health Industry Co., Ltd.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
04/26/2022	04/19/2022	Fresh Farms LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
04/26/2022	04/12/2022	Alymar LLC	Southwest Imports	Foreign Supplier Verification Program (FSVP)

 

• Kingdom Honey Royal Honey VIP contains hidden drug ingredient
• Cougar Secret Honey VIP contains hidden drug ingredient
• Medcare Golden Royal Honey contains hidden drug ingredient
• HoneyGizer™ contains hidden drug ingredient
• ETUMAX VIP Royal Honey for Him contains hidden drug ingredients
• Erkexin contains hidden drug ingredient
• Royal Honey VIP contains hidden drug ingredient
• Secret Miracle Honey contains hidden drug ingredient
• Vital Honey contains hidden drug ingredient
• UPDATED: Helmi’s Honey VIP contains hidden drug ingredient
• UPDATED: X Rated Honey For Men contains hidden drug ingredient

 

FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy

FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections.

APS Pharmacy, located in Palm Harbor, Florida, which compounds drugs intended for human use and drugs intended for animal (veterinary) use, initiated the voluntary nationwide recall via a recall letter dated March 15, 2022. The company has sent recall letters to all patients and animal owners who received the recalled drugs, and they are contacting all customers via telephone calls and emails as part of their recall strategy.

The recalled drugs include “gonadorelin acetate,” “testosterone cypionate in grapeseed oil,” “testosterone cypionate/anastrozole in grapeseed oil,” “testosterone cypionate/DHEA in grapeseed oil,” and “testosterone cypionate/propionate in sesame seed oil” for human use, and “cyclosporin” and “tacrolimus” for animal ophthalmic use. These products were compounded between December 21, 2021, and March 7, 2022. The recalled drugs, lot numbers, and do-not-use beyond date - the date when the compounded drug should no longer be used - are listed here.