Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Emergency Medicine 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), citing the presence of particulate matter identified as stainless steel particles in the solution. The FDA classifies this as a Class I recall, indicating the most serious category associated with potential health risk.
Optimal Balance Pharmacy (Houston, TX) has issued a Class I recall for its Glutathione 200 mg/mL, 30 mL sterile multidose injectable vials. The recall was prompted by out-of-specification results for bacterial endotoxin, indicating microbial contamination of the sterile product. The product was labeled for IM or IV injection use only and available by prescription.
Baxter Healthcare has issued a Class I recall for 500 mL bags of 0.9% Sodium Chloride Injection USP in VIAFLEX plastic containers, NDC 0338-0049-03, packaged 24 units per case. The recall was initiated due to the presence of particulate matter identified as fiberglass within the product.
FDA has classified a Class II recall for Baxter Healthcare Corporation's Daptomycin in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), supplied as a 1,000 mg total dose in a 1000 mL single dose container (NDC 0338-0718-12). The recall was initiated due to current good manufacturing practice (CGMP) deviations, as stated in the FDA enforcement report.
Baxter Healthcare Corporation has issued a Class II recall for its Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100 mL single-dose containers, NDC 0338-9640-12. The FDA classification cites current Good Manufacturing Practice (cGMP) deviations as the reason for the recall.
FDA has classified as Class II a recall of Baxter Healthcare's Nexterone (amiodarone HCl), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, NDC 43066-360-20. The recall reason listed is CGMP (current good manufacturing practice) deviations. No further clinical details are provided in the notice.
FDA has classified a recall of Baxter Healthcare's Vasopressin in 0.9% Sodium Chloride Injection (40 units per 100 mL, 0.4 units/mL, 100 mL single-dose container, NDC 0338-9647-12) as a Class II recall. The source states the action was initiated due to current good manufacturing practice (CGMP) deviations.
A Class II recall has been issued for Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), in 1000-count bottles, NDC 16729-447-17, manufactured by Intas Pharmaceuticals Limited. The recall reason is listed as subpotent drug.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), in 1000-count bottles, NDC 16729-453-17, manufactured by Intas Pharmaceuticals Limited. The FDA classification cites the product as a subpotent drug, meaning the tablets contain less active ingredient than labeled.
Accord Healthcare, Inc. has issued a Class II recall of Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), in 1000-count bottles, NDC 16729-448-17, manufactured by Intas Pharmaceuticals Limited. The recall reason listed is that the product is subpotent.
FDA lists a Class II recall of Accord Healthcare's Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, NDC 16729-458-15, manufactured by Intas Pharmaceuticals. The recall reason stated is that the product is subpotent.
Mallinckrodt Hospital Products Inc. has issued a Class II recall of Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vials, NDC 63004-8710-1 and NDC 63004-8710-2. The recall was initiated due to the presence of particulate matter identified as glass and a stopper piece within the product.
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 recall states that an internal investigation at the firm found the product to contain glass particles, indicating a presence of particulate matter in affected lots.
