Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Oncology from the last 30 days.
Baxter Healthcare Corporation issued a Class I recall for Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06) due to the presence of particulate matter identified as stainless steel particles in the solution. The recall notice does not specify additional details on distribution scope or clinical outcomes.
The FDA has classified a recall of Baxter Healthcare's 0.9% Sodium Chloride Injection USP, 500 mL VIAFLEX plastic containers (NDC 0338-0049-03), as Class I. The recall was issued due to the presence of particulate matter identified as fiberglass in the product.
FDA issued a Class I recall for Optimal Balance Pharmacy's Glutathione 200 mg/mL, 30 mL sterile multidose injectable vials, which also contain ascorbic acid, benzyl alcohol, and sterile water for injection. The recall states the action was prompted by out-of-specification results for bacterial endotoxin, indicating microbial contamination of the sterile product. The product was labeled for intramuscular or intravenous injection use only.
FDA issued a Class II recall notice for Accord Healthcare's Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, NDC 16729-452-17, manufactured by Intas Pharmaceuticals. The notice cites the product as subpotent.
Accord Healthcare, Inc. issued a Class II recall for Levothyroxine Sodium Tablets, USP, 88 mcg, 1000-count bottles, NDC 16729-450-17, manufactured by Intas Pharmaceuticals Limited. The recall was classified as subpotent drug, according to the recall notice.
The FDA has classified a Class II recall for Accord Healthcare, Inc.'s Levothyroxine Sodium Tablets, USP, 100 mcg, distributed in 90-count and 1000-count bottles. The recall reason listed is that the product is subpotent. The tablets were manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc.
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), distributed in 90-count and 1000-count bottles, as a Class II recall. The FDA notice states the reason for recall is that the product is subpotent, meaning the tablets contain less active drug than labeled.
Fresenius Kabi USA is recalling Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vials, NDC 65219-594-20, under a Class I recall designation. According to the recall notice, an internal investigation at the firm found the product to contain glass particulate matter. The recall applies to product manufactured by Fresenius Kabi USA, LLC in Lake Zurich, Illinois.
