fbpx
May 11, 2021

Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil

Summary Company Announcement Date: May 11, 2021 FDA Publish Date: May 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil and Sildenafil […]
May 11, 2021

Ismar Soluciones Dinámicas S de RL de CV – 609690 – 05/04/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Alejandro Diaz Ismar Soluciones Dinámicas S de RL de CV Industria del Vestido45150 Zapopan, Jal.Mexico Issuing […]
May 11, 2021

Crown Wellness, Inc – 610844 – 04/29/2021

Delivery Method: VIA Electronic Mail Product: DrugsFood & Beverages Recipient: Recipient Name Kevin Lockhart/David Black Recipient Title President Crown Wellness, Inc 118 Middle Street, Suite 1020Lake […]
May 11, 2021

Q3D(R2) – Guideline for Elemental Impurities

Submit Comments by 07/12/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
May 11, 2021

S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals

Docket Number: FDA-2018-D-4524 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this document is […]
May 11, 2021

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry

Docket Number: FDA-2018-D-1609 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides a framework to […]
May 11, 2021

S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals

Docket Number: FDA-2017-D-5138 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this guidance is […]
May 10, 2021

Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions

Summary Company Announcement Date: May 07, 2021 FDA Publish Date: May 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to improper storage […]
May 10, 2021

FDA Updates and Press Announcements on NDMA in Ranitidine (Zantac)

Update [2/27/2020] FDA is alerting patients and health care professionals to American Health Packaging’s voluntary recall of ranitidine tablets (150 mg), manufactured by Amneal Pharmaceuticals, LLC. […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0