Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Surgery 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) due to the presence of particulate matter identified as stainless steel particles in the solution. The recall is classified as Class I, indicating the issue involves a risk of serious injury or death.
FDA has classified a recall of Glutathione 200 mg/mL, 30 mL sterile multidose vials manufactured by Optimal Balance Pharmacy as Class I. The recall was initiated due to microbial contamination of sterile products, with out-of-specification results obtained for bacterial endotoxin. The product, intended for IM or IV injection, is compounded with ascorbic acid, benzyl alcohol, and sterile water for injection.
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), packaged 24 units per case. The recall notice states the product contains particulate matter identified as fiberglass. FDA classifies this as a Class I recall, indicating the most serious recall category.
FDA has classified as a Class II recall Baxter Healthcare Corporation's Nexterone (amiodarone HCI) 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, an iso-osmotic dextrose solution, citing current good manufacturing practice (CGMP) deviations. The recalled product carries NDC 43066-360-20 and was manufactured in the USA at Baxter's Deerfield, IL facility.
Baxter Healthcare Corporation has issued a Class II recall for Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), supplied in GALAXY Single-Dose Containers under NDC 0338-3552-48. The recall notice cites CGMP deviations as the reason for the action, according to the FDA recall listing.
The FDA classified a Class II recall for Baxter Healthcare Corporation's Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL), packaged 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 its Vasopressin in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), supplied in 100 mL single-dose containers under NDC 0338-9640-12. The recall was initiated due to current good manufacturing practice (CGMP) deviations, as reported in the recall notice.
The FDA has classified a recall of Accord Healthcare's Levothyroxine Sodium Tablets, USP, 50 mcg, 1000-count bottles (NDC 16729-448-17) as a Class II recall due to the drug being subpotent. The product was manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc.
Accord Healthcare, Inc. issued a Class II recall for Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), distributed in 90-count and 1000-count bottles under specified NDC numbers. The recall was classified due to the product being subpotent, according to the recall notice. The tablets were manufactured by Intas Pharmaceuticals Limited for Accord Healthcare, Inc.
FDA recall notice reports a Class II recall of Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), manufactured for Accord Healthcare and produced by Intas Pharmaceuticals, distributed in 90-count and 1000-count bottles. The recall cites the product as subpotent, meaning the tablets contain less active drug than labeled.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), distributed in 90-count and 1000-count bottles, due to the product being subpotent. The affected lots were manufactured by Intas Pharmaceuticals Limited in India and distributed under NDC 16729-456-15 and 16729-456-17.
Hikma Pharmaceuticals USA/Exelan Pharmaceuticals has issued a Class II recall for Ramipril Capsules USP, 10 mg, in 100-count and 500-count bottles. The recall states that an out-of-specification result was obtained for the process impurity dicyclohexylurea (DCU) during degradation testing. The affected product was manufactured by West-Ward Columbus Inc. for Exelan Pharmaceuticals.
Fresenius Kabi USA has issued a Class I recall for Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL, 20 mL vial (NDC 65219-594-20). The company's internal investigation found the product to contain glass particulate matter, according to the recall notice.
