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Research, guidelines, and safety alerts for your specialty.
Recent updates in Infectious Diseases 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). The recall notice states the affected lots contain particulate matter identified as stainless steel particles in the solution.
FDA has classified a recall of Baxter Healthcare's 0.9% Sodium Chloride Injection USP, 500 mL VIAFLEX plastic containers (NDC 0338-0049-03), as a Class I recall. The recall notice states that particulate matter identified as fiberglass was found in the product.
A Class II recall notice reports that Baxter Healthcare Corporation is recalling its Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL) single-dose GALAXY container, NDC 0338-9549-50. 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 Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL, supplied in GALAXY 50 mL single dose containers (NDC 43066-995-24), citing current good manufacturing practice (CGMP) deviations. The recall notice does not specify the exact nature of the deviation or associated clinical risk.
Baxter Healthcare Corporation issued a Class II recall for 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 FDA recall notice attributes the action to current good manufacturing practice (CGMP) deviations, without specifying further details on the nature of the deviation or associated clinical risk.
Baxter Healthcare Corporation has issued a Class II recall for Daptomycin in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), supplied in 1000 mL single dose containers under NDC 0338-0718-12. The recall notice cites current Good Manufacturing Practice (CGMP) deviations as the reason for the action.
The FDA recall notice reports a Class II recall of Baxter Healthcare's Vancomycin Injection, USP, in 0.9% Sodium Chloride (1g per 200 mL) supplied in GALAXY Single-Dose Containers, NDC 0338-3583-01. The notice attributes the recall to current good manufacturing practice (CGMP) deviations.
Fresenius Kabi USA, LLC has issued a Class I recall of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, NDC 65219-594-20. The recall follows an internal investigation by the firm that found the product to contain glass particulate matter.
