Image A person commits a crime, and the detective uses DNA evidence collected from the crime scene to track the criminal down. An outbreak of foodborne illness makes people sick, and the U.S. Food and Drug Administration (FDA) uses DNA evidence to track down the bacteria that caused it. Sound far-fetched? It’s not. The FDA…
Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
Summary Company Announcement Date: November 24, 2023 FDA Publish Date: November 27, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to crystallization formation Company Name: Novartis Pharmaceuticals Corporation Brand Name: Brand Name(s) Product Description: Product Description Sandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mL Company Announcement FOR IMMEDIATE RELEASE – November…
Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: VariSoft Infusion Sets Product Codes: FPA Model Numbers: 1002827, 1002828, 1002830 Lot Numbers: 5388367; 5388357; 5388371; 5388362; 5388368; 5388366; 5388372; 5388376 Manufacturing Dates: April 1,…
Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder Due to the Presence of Benzene
Summary Company Announcement Date: November 24, 2023 FDA Publish Date: November 24, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company Name: Insight Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal SprayPowder Company Announcement TARRYTOWN, N.Y., Nov. 24, 2023 (GLOBE NEWSWIRE) —…
Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mg/mL Due to Presence of Microbial Contamination
Summary Company Announcement Date: November 17, 2023 FDA Publish Date: November 21, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination identified as Penicillium brevicompactum Company Name: Bayer Brand Name: Brand Name(s) Product Description: Product Description Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles Company Announcement FOR IMMEDIATE RELEASE –…
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication
Date Issued: November 21, 2023 The U.S. Food and Drug Administration (FDA) is providing additional information about a product recall related to the use of SoClean2 and SoClean3 equipment used to clean, sanitize, or disinfect CPAP devices and accessories. The company’s recall consists of a new User Manual with additional instructions for use and a…
Noah’s Wholesale, LLC Issues Voluntary Nationwide Recall of the Rock Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: October 18, 2023 FDA Publish Date: November 21, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared drug, Sildenafil Company Name: Noah’s Wholesale, LLC Brand Name: Brand Name(s) Noah’s Wholesale, LLC Product Description: Product Description Dietary Supplement with undeclared Sildenafil Company Announcement FOR IMMEDIATE RELEASE – October 18, 2023…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On October 24, 2023, the FDA approved ivosidenib (brand name…
Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
November 20, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the FDA further evaluates this issue. In June 2023, Cardinal Health began distributing Monoject syringes branded as “Cardinal Health” Monoject syringes. These…
Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons
Summary Company Announcement Date: November 15, 2023 FDA Publish Date: November 15, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety Potential Safety Concerns Company Name: Kilitch Healthcare India Limited Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Lubricant Eye Drops & Multi-Symptom Eye Drops Company Announcement FOR…