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In the United States, the dominant manufacturer is Hospira (a Pfizer company) , which produces it under cGMP conditions with documented: Sterility and endotoxin testing (USP , ) Particulate matter limits (USP ) pH specification (typically 4.5–7.0) Tamper-evident packaging with visible lot/NDC markings and a flip-off cap printed with the manufacturer name The benzyl alcohol does not sterilize the water — it suppresses microbial growth in a previously sterile, sealed vial that is punctured repeatedly during multi-use reconstitution