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Research, guidelines, and safety alerts for your specialty.
Recent updates in Pathology from the last 30 days.
Baxter Healthcare Corporation issued a Class I recall of Dextrose Injection, USP, 70%, in 2000 mL bags (NDC 00338-0719-06) due to the presence of particulate matter in the solution, identified as stainless steel particles. The recall notice does not provide additional detail on lot numbers, distribution scope, or reported adverse events.
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 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 for Daptomycin in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), supplied as single dose containers with 24 bags per carton, NDC 0338-0714-24. The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, as stated in the recall notice.
FDA issued a Class I recall for Optimal Balance Pharmacy's Glutathione 200 mg/mL, 30 mL sterile multidose vials, used for IM or IV injection. The recall was initiated after out-of-specification results for bacterial endotoxin indicated microbial contamination of the sterile product. The product was compounded with ascorbic acid, benzyl alcohol, and sterile water for injection.
Baxter Healthcare Corporation issued a Class I recall of 0.9% Sodium Chloride Injection USP 500 mL in VIAFLEX plastic containers, packaged 24 units per case, NDC 0338-0049-03. The recall states particulate matter was identified in the product as fiberglass. FDA classifies this as a Class I recall, indicating the most serious category of recall.
FDA has classified a Class II recall for Baxter Healthcare's Vancomycin Injection, USP in 5% Dextrose, 1 g per 200 mL, supplied in GALAXY Single-Dose Containers (NDC 0338-3552-48). The recall notice cites CGMP deviations as the reason for the action.
Baxter Healthcare Corporation issued a Class II recall for 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. The recall notice cites CGMP (Current Good Manufacturing Practice) deviations as the reason for action; no further details on the specific deviation or clinical impact were provided in the source.
Mallinckrodt Hospital Products Inc. issued a Class II recall of Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vials, due to the presence of particulate matter identified as glass and stopper piece fragments. The recall covers product distributed under NDC 63004-8710-1 and NDC 63004-8710-2, manufactured for Mallinckrodt ARD LLC of Bridgewater, NJ.
Accord Healthcare, Inc. is recalling 1000-count bottles of Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), manufactured by Intas Pharmaceuticals Limited, under an FDA Class II recall designation. The stated reason for the recall is that the product is subpotent.
Accord Healthcare, Inc. issued a Class II recall of Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), supplied in 1000-count bottles under NDC 16729-453-17. The product, manufactured by Intas Pharmaceuticals Limited in India, was recalled due to being subpotent.
Accord Healthcare, Inc. issued a Class II recall for 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 cited is that the product is subpotent.
The FDA has classified a recall of Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), manufactured by Intas Pharmaceuticals for Accord Healthcare, as Class II. The recall covers 90-count bottles (NDC 16729-457-15) and 1000-count bottles (NDC 16729-457-17) due to the product being subpotent, according to the recall notice.
FDA reported a Class I recall of Fresenius Kabi USA's Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL vials, NDC 65219-594-20. The company's internal investigation found the product to contain glass particulate matter. Class I recalls are used by FDA for situations where use of the product could cause serious injury or death.
