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July 15, 2022

Public Notification: Adam’s Secret Extra Strength 3000 Platinum (White Packaging) contains hidden drug ingredient

[7-15-2022] The Food and Drug Administration is advising consumers not to purchase or use Adam’s Secret Extra Strength 3000 Platinum (White), a product promoted and sold […]
July 15, 2022

ACRX Specialty Pharmacy Inc – 609518 – 07/13/2022

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Eghomware J. Igbinovia Recipient Title Pharmacist-in-Charge/Owner ACRX Specialty Pharmacy Inc 3200 Soaring Gulls DrSTE 101Las […]
July 15, 2022

Signa S.A. de C.V. – 605219 – 07/07/2022

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Jeff Watson Recipient Title President & Chief Executive Officer Signa S.A. de C.V. Apotex Inc. […]
July 14, 2022

Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations Guidance for Sponsor-Investigators

Docket Number: FDA-2021-D-1139 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing […]
July 14, 2022

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format

Docket Number: FDA-2019-D-1615 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance provides recommendations for developing the content and format of a […]
July 14, 2022

Lewiston Feed & Produce Company – 613123 – 09/15/2021

Delivery Method: VIA UPS Product: Animal & VeterinaryDrugs Recipient: Recipient Name Steven R. Kanz Recipient Title President Lewiston Feed & Produce Company 105 E. Main StreetLewiston, […]
July 14, 2022

Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy – 611130 – 06/27/2022

Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Clayton McGhan, MHA Recipient Title Interim West Hawaii Regional CEO Hawaii Health Systems Corporation dba […]
July 13, 2022

Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to the Potential Presence of Visible Particulate

Summary Company Announcement Date: July 13, 2022 FDA Publish Date: July 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of visible […]
July 13, 2022

Expanded Access (Compassionate Use) Submission Data

CDER, CBER and CDRH Expanded Access INDs and Protocols (2016-2020) On this page you will find: The Center for Drug Evaluation and Research (CDER) and the […]
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