fbpx
April 8, 2021

About Mineral – 613984 – 04/07/2021

Product: Drugs Recipient: Recipient Name Hyun Eun Lee About Mineral 3063 W. Chapman Ave., #6301Orange, CA 92868United States [email protected] DATE:             April 7, 2021 RE:             […]
April 8, 2021

October – December 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen Stevens-Johnson Syndrome FDA is evaluating the need for regulatory action. Ajovy (fremanezumab) Vyepti (eptinezumab) Anaphylactic reaction FDA is evaluating the need for regulatory action. Albuterol […]
April 8, 2021

Allure Imports – 613211 – 04/07/2021

Product: Animal & VeterinaryDrugs Recipient: Recipient Name Cory Chiarello Allure Imports 405 E Easterday Ave., Unit 2Sault Sainte Marie, MI 49783United States [email protected] WARNING LETTER Date: […]
April 7, 2021

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic […]
April 7, 2021

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil

Summary Company Announcement Date: April 05, 2021 FDA Publish Date: April 06, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: […]
April 7, 2021

FDA approves new dosing regimen for cetuximab

On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) […]
April 6, 2021

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil

Summary Company Announcement Date: April 05, 2021 FDA Publish Date: April 06, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: […]
April 6, 2021

Public Notification: PremierZen Black 5000 contains hidden drug ingredients

[04/06/2021] Update: This product has been recalled by Namoo Enterprise LLC. See the company’s press release for more information on the recall. This product was sold by the seller All-R0under via Amazon fulfillment and eBay. See […]
April 6, 2021

Public Notification: Triple SupremeZen Gold 3500 contains hidden drug ingredients

[04/06/2021] Update: This product has been recalled by NANA Collection LLC. See the company’s press release for more information on the recall. This product was sold by E-Factory NY via Amazon fulfillment. See […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0