Baxter Healthcare Corporation — Class II: Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Sing
Baxter Healthcare Corporation has initiated a Class II recall for Clindamycin Injection USP in 5% Dextrose (900 mg per 50 mL) due to CGMP deviations. The recall involves products in GALAXY single-dose containers and is currently listed as ongoing.
This affects Baxter Healthcare Corporation, healthcare facilities utilizing Clindamycin Injection USP (NDC 0338-3814-50), and personnel involved in sterile drug manufacturing and quality oversight.
A Class II designation suggests that the CGMP deviations could potentially cause temporary or medically reversible adverse health consequences, though the probability of serious harm is remote. For regulatory professionals, this indicates a breakdown in manufacturing standards that necessitated a formal market action to mitigate risk. The ongoing status implies that the firm is still in the process of identifying or recovering affected units.
Quality and manufacturing teams should review current CGMP compliance for sterile injectable lines. Regulatory and supply chain departments should monitor the status of NDC 0338-3814-50 and coordinate with clinical sites regarding the ongoing recall status of affected lots.
Class II. Reason: CGMP Deviations. Product: Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.. Firm: Baxter Healthcare Corporation (Deerfield IL United States). Status: Ongoing.
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