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April 15, 2020

Hospira Issues a Voluntary Nationwide Recall for Labetalol Hydrochloride Injection, USP, Due to the Potential of Cracked Glass at the Rim Surface of the Vials

Summary Company Announcement Date: February 22, 2018 FDA Publish Date: April 13, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Potential Of […]
April 15, 2020

Apace Packaging LLC Issues Voluntary Nationwide Recall of Acyclovir (Lot 19900) Due to Product Mix-up

Summary Company Announcement Date: February 14, 2018 FDA Publish Date: April 13, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Product Mix-up […]
April 15, 2020

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash Due to Complaints Received on Potential Product Contamination which Compromises Sterility

Summary Company Announcement Date: January 28, 2018 FDA Publish Date: April 13, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential microbial contamination which […]
April 15, 2020

Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA’s Cooperation to Restore Access for Patients with Medical Necessity

Summary Company Announcement Date: January 25, 2018 FDA Publish Date: April 13, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to adverse event […]
April 15, 2020

Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling

Summary Company Announcement Date: January 18, 2018 FDA Publish Date: April 13, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Mislabeling Company […]
April 15, 2020

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

Summary Company Announcement Date: January 16, 2018 FDA Publish Date: April 14, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Presence […]
April 15, 2020

Determining Whether to Submit an ANDA or a 505(b)(2) Application

Docket Number: FDA-2017-D-5974 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to serve […]
April 15, 2020

Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations

Docket Number: FDA-2012-D-0096 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 15, 2020

Development and Use of Risk Minimization Action Plans

Docket Number: FDA-2004-D-0441 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
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