Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Anesthesiology 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). The recall was prompted by identification of particulate matter, described as stainless steel particles, within the solution.
The FDA recall notice describes a Class II recall of Baxter Healthcare's Nexterone (amiodarone HCl) 360 mg/200 mL (1.8 mg/mL) injection in GALAXY Single-Dose Containers, NDC 43066-360-20. The notice states the recall is due to current Good Manufacturing Practice (CGMP) deviations. No further details on the specific defect or associated clinical risk are provided in the source text.
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), in a 100 mL Single-Dose Container (NDC 0338-9647-12). The recall notice cites CGMP (current Good Manufacturing Practice) deviations as the reason for the action.
Optimal Balance Pharmacy has issued a Class I recall for its 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 of 0.9% Sodium Chloride Injection USP 500 mL in VIAFLEX plastic containers (24 units per case, NDC 0338-0049-03), the source states. The recall was initiated due to the presence of particulate matter identified as fiberglass in the product.
The FDA has classified as a Class II recall a lot of Vancomycin Injection, USP, in 0.9% Sodium Chloride (1g per 200 mL, 5 mg/mL) supplied in Baxter's GALAXY Single-Dose Container, NDC 0338-3583-01. The recall was initiated due to current good manufacturing practice (CGMP) deviations, as reported in the FDA enforcement notice.
The FDA has classified a recall of Baxter Healthcare's Vancomycin Injection, USP in 5% Dextrose (1 g per 200 mL, 5 mg/mL) in GALAXY Single-Dose Containers as a Class II recall. The source states the recall was initiated due to current good manufacturing practice (CGMP) deviations, with the affected product identified by NDC 0338-3552-48.
FDA has classified as Class I a recall by Fresenius Kabi USA, LLC of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL vials, NDC 65219-594-20. The firm's internal investigation found the product contained glass particulate matter.
