Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Intensive Care Medicine from the last 30 days.
Baxter Healthcare Corporation issued a Class I recall for Dextrose Injection, USP, 70%, in 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 specify additional details on affected lot numbers or clinical outcomes.
Baxter Healthcare Corporation has issued a Class II recall for Nexterone (amiodarone HCI) 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, an iso-osmotic solution in dextrose (NDC 43066-360-20). The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, as reported in the FDA recall notice.
Optimal Balance Pharmacy has issued a Class I recall of Glutathione 200 mg/mL, 30 mL sterile multidose vials intended for IM or IV injection. The recall was initiated after out-of-specification results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile product.
Baxter Healthcare Corporation has issued a Class I recall for 0.9% Sodium Chloride Injection USP 500 mL in VIAFLEX plastic containers (NDC 0338-0049-03, 24 units per case) due to the presence of particulate matter identified as fiberglass. The recall notice does not specify additional details on distribution scope or clinical outcomes associated with the affected lots.
Baxter Healthcare Corporation has issued a Class II recall for Vasopressin in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), supplied in 100 mL single-dose containers under NDC 0338-9647-12. 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 Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) supplied in GALAXY Single-Dose Containers, NDC 0338-3583-01. 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 Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100 mL Single-Dose Container, NDC 0338-9640-12. The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, according to the source notice.
FDA has classified a Class II recall of Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), manufactured for Accord Healthcare, Inc. and made by Intas Pharmaceuticals, in 90-count and 1000-count bottles. The recall reason cited is that the product is subpotent.
A Class II recall has been issued for Accord Healthcare, Inc.'s Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, NDC 16729-455-17, manufactured by Intas Pharmaceuticals Limited. The recall notice cites the product as a subpotent drug.
Mallinckrodt Hospital Products Inc. issued a Class II recall of Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, manufactured for Mallinckrodt ARD LLC, Bridgewater, NJ, NDC 63004-8710-1 and NDC 63004-8710-2. The recall was initiated due to the presence of particulate matter identified as glass and stopper piece within the product.
Accord Healthcare, Inc. issued a Class II recall for Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), supplied in 1000-count bottles under NDC 16729-449-17. The manufacturer, Intas Pharmaceuticals Limited, identified the product as subpotent, according to the recall notice. The tablets were manufactured for Accord Healthcare, Inc. of Raleigh, NC.
Accord Healthcare, Inc. has issued a Class II recall of Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), in 90-count bottles, NDC 16729-458-15, manufactured by Intas Pharmaceuticals Limited. The recall reason listed is that the drug is subpotent.
Fresenius Kabi USA has issued a Class I recall for Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL) vials, NDC 65219-594-20. The company's internal investigation found that the product contained glass particulate matter. The FDA has designated this a Class I recall, indicating the most serious recall category.
