FDA-Drug2016-03-23Class III

NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61

Pharmedium Services, LLC
Hazard

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Sold states
Nationwide
Affected count
6,816 bags
Manufactured in
150 N Field Dr Ste 350, Lake Forest, IL, United States
Products
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0777-2016

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