PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: March 23, 2016 Initiated: December 31, 2015 #D-0777-2016

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Pharmedium Services, LLC
Units Affected
6,816 bags
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Pharmedium Services, LLC. Units affected: 6,816 bags.
Why was this product recalled?
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Which agency issued this recall?
This recall was issued by the FDA Drug on March 23, 2016. Severity: Low. Recall number: D-0777-2016.