Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Preventive Medicine from the last 30 days.
Baxter Healthcare Corporation has issued a Class I recall for Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06), citing the presence of particulate matter identified as stainless steel particles in the solution. The recall notice does not provide additional details on the scope of distribution or associated adverse events.
FDA reports a Class I recall of Optimal Balance Pharmacy's Glutathione 200 mg/mL sterile multidose injection vials, intended for IM or IV use. The recall was initiated after out-of-specification results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile product. FDA classifies this as a Class I recall, its most serious designation.
Baxter Healthcare Corporation has issued a Class I recall for its 0.9% Sodium Chloride Injection USP, 500 mL, in VIAFLEX plastic containers (NDC 0338-0049-03, 24 units per case). The recall was initiated due to the presence of particulate matter identified as fiberglass in the product.
The FDA has classified a recall by Baxter Healthcare Corporation as Class II for Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL), supplied in Galaxy 100 mL Single Dose Containers under NDC 0338-9557-12. The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, according to the FDA notice.
Baxter Healthcare Corporation has issued a Class II recall for CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL, supplied in GALAXY Single-Dose Containers under NDC 43066-016-10. The recall notice cites current Good Manufacturing Practice (CGMP) deviations as the reason for the action.
Baxter Healthcare Corporation has issued a Class II recall for Daptomycin in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), supplied as single dose containers in 24-bag cartons under NDC 0338-0714-24. The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations, according to the recall notice.
FDA has classified as Class II a recall by Baxter Healthcare Corporation of Vasopressin in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), in 100 mL single-dose containers, NDC 0338-9640-12. The recall was initiated due to current good manufacturing practice (cGMP) deviations, according to the notice.
The FDA has classified a Class II recall for Accord Healthcare, Inc.'s Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), supplied in 1000-count bottles under NDC 16729-449-17. The recall reason listed is that the product is subpotent, meaning the tablets contain less active drug than labeled. The product was manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc. of Raleigh, NC.
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, NDC 16729-455-17, manufactured by Intas Pharmaceuticals Limited in India. The recall is classified as Class II and cites the product as subpotent.
The FDA has issued a Class II recall for Accord Healthcare, Inc.'s Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), in 90-count bottles, NDC 16729-458-15, manufactured by Intas Pharmaceuticals Limited. The recall notice cites the product as subpotent.
Accord Healthcare, Inc. has issued a Class II recall of Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), supplied in 1000-count bottles under NDC 16729-447-17. The product, manufactured by Intas Pharmaceuticals Limited in India, was recalled due to being subpotent.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), distributed in 90-count and 1000-count bottles, manufactured by Intas Pharmaceuticals Limited in India. The recall states the affected lots are subpotent, meaning the tablets contain less active drug than labeled.
Fresenius Kabi USA has issued a Class I recall for Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, NDC 65219-594-20. The company's internal investigation found the product to contain glass particulate matter.
