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March 26, 2021

S&B Shopper LLC Issues Voluntary Nationwide Recall of Imperial Extreme 2000mg Due to Presence of Undeclared Sildenafil and Tadalafil

Summary Company Announcement Date: March 25, 2021 FDA Publish Date: March 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil & Tadalafil […]
March 25, 2021

FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients

For Immediate Release: March 25, 2021 Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron […]
March 25, 2021

Takeda Issues US Recall of NATPARA® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate

Summary Company Announcement Date: September 05, 2019 FDA Publish Date: September 05, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of rubber […]
March 25, 2021

BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States

Summary Company Announcement Date: March 24, 2021 FDA Publish Date: March 24, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Aspergillus penicillioides contamination […]
March 25, 2021

Benzedrex (propylhexedrine): Drug Safety Communication – FDA Warns that Abuse and Misuse of the Nasal Decongestant Causes Serious Harm

[Posted 03/25/2021] AUDIENCE: Consumer, Patient, Health Professional, Pharmacy   ISSUE: The FDA is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to […]
March 25, 2021

Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization

Summary Company Announcement Date: March 24, 2021 FDA Publish Date: March 25, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Crystalization Company […]
March 25, 2021

FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm

In response to increasing reports of abuse and misuse of propylhexedrine, we reviewed several sources of data. These included calls to U.S. poison control centers, case […]
March 25, 2021

Durisan Hand Sanitizer Recall Due to Microbial Contamination

Summary Company Announcement Date: March 24, 2021 FDA Publish Date: March 24, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to microbial contamination […]
March 24, 2021

Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs

FDA announced in October 2020 the standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products became available for signature by the states. This […]
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