foundmatterdb

Field reports on stuff that let you down

FDA recallMedicationsClass II· Baxter Healthcare Corporation

Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, st…

Official notice from a government agency or its published feed.

Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
Reason: CGMP Deviations
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

Hazard: CGMP Deviations

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