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The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.
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FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-type-non-cancerous-tumors
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Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identifi
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Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections
Unomedical A/S is recalling their Varisoft infusion set due to the connector detaching more easily than expected, thereby interrupting the delivery of insulin.
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Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder Due to the Presence of Benzene
Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder to the consumer level. A recent review by our manufacturer and their third- party lab found that samples fr
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FDA Roundup: November 21, 2023
FDA Roundup: November 21, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-november-21-2023
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Noah’s Wholesale, LLC Issues Voluntary Nationwide Recall of the Rock Due to Presence of Undeclared Sildenafil
Miami Gardens, Florida, Noah’s Wholesale, LLC is voluntarily recalling one lot of the rock# 03032021,exp:12/2027,1200 mg/capsule, to the consumer level. FDA analysis has found the product to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found
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Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mg/mL Due to Presence of Microbial Contamination
Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.
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Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
Cardinal Health Monoject syringes have demonstrated recognition and compatibility issues with certain infusion pumps.
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FDA Roundup: November 17, 2023
FDA Roundup: November 17, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-november-17-2023