Baxter Healthcare Corporation — Class II: Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg to
Baxter Healthcare Corporation has initiated a Class II recall for Daptomycin in 0.9% Sodium Chloride Injection (1,000 mg per 100 mL) due to CGMP deviations. The recall involves NDC 0338-0718-12 and is currently listed as an ongoing enforcement action.
This recall affects Baxter Healthcare Corporation, healthcare facilities utilizing sterile daptomycin premixed injections, and professionals in quality assurance and manufacturing compliance.
A Class II recall due to CGMP deviations suggests that while the health hazard may not be immediate or severe, there is a potential for temporary or medically reversible adverse health consequences. For regulatory professionals, this underscores the importance of strict adherence to validated manufacturing processes for sterile injectables. The source does not specify the exact nature of the deviation, which may indicate issues ranging from environmental monitoring failures to equipment calibration errors.
Quality units should verify if any held inventory is subject to this recall and isolate affected lots. Manufacturing teams should evaluate the specific nature of the CGMP deviations to ensure similar processes are not compromised. Supply chain leads should coordinate with clinical sites to manage potential shortages of daptomycin premixed solutions.
Class II. Reason: CGMP Deviations. Product: Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.. Firm: Baxter Healthcare Corporation (Deerfield IL United States). Status: Ongoing.
Open in openFDA / FDA.gov