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Research, guidelines, and safety alerts for your specialty.
Recent updates in Vascular Surgery from the last 30 days.
Baxter Healthcare Corporation has issued a Class I recall for Dextrose Injection, USP, 70%, in 2000 mL bags (NDC 00338-0719-06), citing the presence of particulate matter identified as stainless steel particles in the solution. The FDA classifies Class I recalls as involving situations where use of the product could cause serious adverse health consequences or death.
A Class II recall has been issued for Mylan Pharmaceuticals' Prasugrel Tablets, USP, 10mg (30-count bottles, NDC 0378-5186-93). The recall notice states the product failed dissolution specifications and did not meet 18-month stability testing acceptance criteria.
Baxter Healthcare Corporation issued a Class I recall for 0.9% Sodium Chloride Injection USP, 500 mL VIAFLEX plastic containers (NDC 0338-0049-03, 24 units per case). The recall notice states the action was prompted by the presence of particulate matter identified as fiberglass in the product.
The FDA has classified a recall of Baxter Healthcare Corporation's Nexterone (amiodarone HCl), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Containers, as a Class II recall. The recall notice cites current Good Manufacturing Practice (CGMP) deviations as the reason for the action, according to the source. No further clinical details were provided in the source text.
FDA has classified as Class II a recall by Baxter Healthcare Corporation of Vancomycin Injection, USP in 5% Dextrose (1 g per 200 mL, 5 mg/mL) supplied in GALAXY Single-Dose Containers, NDC 0338-3552-48. The recall notice cites CGMP deviations as the reason for the action.
A Class II recall notice states that Baxter Healthcare Corporation is recalling 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), due to current Good Manufacturing Practice (CGMP) deviations. The notice does not specify the nature of the deviation or associated clinical risk beyond classifying it as Class II.
The FDA has classified as Class II a recall by Baxter Healthcare Corporation of Vasopressin in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), in 100 mL single-dose containers, NDC 0338-9647-12. The recall notice cites current Good Manufacturing Practice (CGMP) deviations as the reason for the action.
A Class II recall has been issued for Ramipril Capsules USP, 10 mg, in 100- and 500-count bottles manufactured for Exelan Pharmaceuticals and made by West-Ward Columbus Inc. The recall was initiated after an out-of-specification result was obtained for a process impurity, dicyclohexylurea (DCU), according to the recall notice.
