Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Toxicology from the last 30 days.
A Class I recall has been issued for Baxter Healthcare Corporation's 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 FDA considers use of the affected product could cause serious health consequences.
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 as a 100 mL single-dose container under NDC 0338-9647-12. The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations, as reported in the recall notice.
Baxter Healthcare Corporation has issued a Class II recall of Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL), packaged in GALAXY Single-Dose Containers under NDC 0338-3583-01. The recall was initiated due to current good manufacturing practice (CGMP) deviations, as classified in the FDA recall notice. No specific patient injury or defect details beyond the CGMP deviation classification were reported in the source text.
A Class II recall has been issued for Mylan Pharmaceuticals' Prasugrel Tablets, USP, 10mg, 30-count bottles, NDC 0378-5186-93. The recall states the product failed dissolution specifications during 18-month stability testing. The affected lot was manufactured for Mylan Pharmaceuticals Inc. in India.
The FDA has classified a recall of Optimal Balance Pharmacy's Glutathione 200 mg/mL, 30 mL sterile multidose vials as Class I. The recall was initiated after out-of-specification results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile injectable product intended for IM or IV use.
Baxter Healthcare Corporation has issued a Class I recall for 0.9% Sodium Chloride Injection USP, 500 mL, in VIAFLEX Plastic Containers (24 units per case, NDC 0338-0049-03), due to the presence of particulate matter identified as fiberglass. The recall notice classifies this as a Class I event, the FDA's most serious recall category, indicating use of the affected product could cause serious adverse health consequences.
Baxter Healthcare Corporation has issued a Class II recall of Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), supplied in GALAXY Single-Dose Containers (NDC 0338-3552-48). The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, according to the recall notice.
Accord Healthcare, Inc. has issued a Class II recall of Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, NDC 16729-453-17, manufactured by Intas Pharmaceuticals Limited. The recall notice cites the product as a subpotent drug.
Hikma Pharmaceuticals USA (manufactured by West-Ward Columbus Inc. for Exelan Pharmaceuticals) has issued a Class II recall of Ramipril Capsules USP, 10 mg, in 100-capsule (NDC 76282-673-01) and 500-capsule (NDC 76282-673-05) bottles. The recall notice states the action was taken because an out-of-specification result was obtained for a process impurity, dicyclohexylurea (DCU), indicating the product failed impurities/degradation specifications.
FDA has classified a Class II recall for Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), manufactured by Intas Pharmaceuticals for Accord Healthcare, Inc. The recall covers 90-count bottles (NDC 16729-457-15) and 1000-count bottles (NDC 16729-457-17) due to the product being subpotent.
Accord Healthcare, Inc. has issued a Class II recall of Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), in 1000-count bottles due to the drug being subpotent, according to the recall notice. The product, manufactured by Intas Pharmaceuticals Limited in India and distributed under NDC 16729-447-17, is prescription only.
Mallinckrodt Hospital Products Inc. initiated a Class II recall of Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vials, NDC 63004-8710-1 and NDC 63004-8710-2, due to the presence of particulate matter identified as glass and stopper pieces.
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 particulate matter. Class I recalls are designated for situations where use of the product could cause serious health consequences.
