Safety alertSource: FDA Drug Enforcement Reports

Class II recall: Baxter Healthcare Corporation: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100

Baxter Healthcare Corporation has issued a Class II recall of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL, supplied in Galaxy 100 mL single dose containers (NDC 0338-9557-12). The recall was initiated due to current good manufacturing practice (CGMP) deviations, as reported in the FDA enforcement notice.

Most relevant for: Clinicians and facilities that stock or administer this specific dexmedetomidine injection product for sedation.

Read the original at FDA Drug Enforcement Reports

Summary written by an AI model from the source text and dated by the source's publication date. Check the original before acting on it. How MedFollow selects and summarizes updates.

Informational only. Not medical advice. Not a substitute for clinical judgment. Always consult current guidelines and your own clinical judgment.

Specialties

More pediatrics updates

Get updates for your specialty