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Research, guidelines, and safety alerts for your specialty.
Recent updates in Pulmonology from the last 30 days.
Optimal Balance Pharmacy has issued a Class I recall for its Glutathione 200 mg/mL sterile multidose vials, intended for IM or IV injection. According to the recall notice, out-of-specification results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile product.
The FDA has classified a recall of Baxter Healthcare Corporation's Nexterone (amiodarone HCl) 360 mg/200 mL (1.8 mg/mL) solution, supplied in GALAXY Single-Dose Containers, as Class II. The recall notice attributes the action to current good manufacturing practice (CGMP) deviations. The affected lot carries NDC 43066-360-20 and was manufactured by Baxter Healthcare Corporation in Deerfield, IL.
FDA has classified a Class II recall for Baxter Healthcare Corporation's Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL, supplied in GALAXY 50 mL single dose containers under NDC 43066-995-24. The recall was initiated due to CGMP deviations, according to the FDA recall notice. No specific patient injury or clinical outcome data were included in the source text.
The FDA has classified a recall of Baxter Healthcare's Clindamycin Injection USP in 5% Dextrose (900 mg/50 mL, NDC 0338-4114-50) supplied in GALAXY 50 mL single-dose containers as a Class II recall. The listed reason is cGMP deviations, according to the recall notice; no further details on the specific deviation or clinical risk are provided in the source text.
FDA has classified a Class II recall for Baxter Healthcare Corporation's Clindamycin Injection USP in 5% Dextrose (600 mg per 50 mL, 12 mg/mL) supplied in GALAXY 50 mL single-dose containers, NDC 0338-3612-50. The recall was issued due to current good manufacturing practice (CGMP) deviations, according to the source notice.
The FDA has classified as Class II a recall by Baxter Healthcare Corporation of Vancomycin Injection, USP, in 0.9% Sodium Chloride (1g per 200 mL, 5 mg/mL) 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; no further clinical detail is provided in the source.
The FDA has classified a recall of Fresenius Kabi USA's Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL) vials, NDC 65219-594-20, as Class I. According to the recall notice, an internal investigation by the manufacturer found glass particulate matter present in the product. Class I recalls are used by the FDA to denote situations where use of the product could cause serious injury or death.
