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October 5, 2021

Walfer Corporation dba The Medicine Shoppe Pharmacy – 611017 – 09/17/2021

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Wayne Wallace Recipient Title Owner Walfer Corporation dba The Medicine Shoppe Pharmacy 3524 B Tamiami TrlPort […]
October 5, 2021

True Chemical Solutions, LLC – 616672 – 09/29/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Travis Pitcock Recipient Title Chief Executive Officer True Chemical Solutions, LLC 6215 W. County Road 112Midland, […]
October 5, 2021

Limpo Quimicos, SA de CV – 608859 – 09/30/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Santiago Alvarado Recipient Title General Director Limpo Quimicos, SA de CV Privada Jose Silvestre Aramberri No. […]
October 5, 2021

Healthy Foods & Nutrition Lab de Mexico S.A. de C.V. – 609608 – 09/29/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Juan Pablo Maza Gomez Recipient Title CEO Healthy Foods & Nutrition Lab de Mexico S.A. de […]
October 5, 2021

Ardil Comercial S.R.L. – 612018 – 09/22/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ms. Cecilia Ramirez Recipient Title Administrative Director Ardil Comercial S.R.L. Pastora Elida Km 19 No. 03, Apto. […]
October 4, 2021

Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry

Docket Number: FDA-2017-D-2163 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants, manufacturers, packagers, and distributors (collectively […]
October 4, 2021

Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation

Docket Number: FDA-2016-D-2817 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance discusses what types of information you, the applicant, should submit […]
October 1, 2021

FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia

On October 1, 2021, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) for adult patients with relapsed or refractory B-cell precursor acute […]
October 1, 2021

Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene

Summary Company Announcement Date: October 01, 2021 FDA Publish Date: October 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company […]
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