PlainRecalls
FDA Drug Moderate Class II Terminated

Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

Reported: July 11, 2018 Initiated: June 14, 2018 #D-0899-2018

Product Description

Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

Reason for Recall

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

Details

Recalling Firm
SCA Pharmaceuticals, LLC
Units Affected
1,882 bags
Distribution
Product was distributed throughout the United States.
Location
Windsor, CT

Frequently Asked Questions

What product was recalled?
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT. Recalled by SCA Pharmaceuticals, LLC. Units affected: 1,882 bags.
Why was this product recalled?
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 11, 2018. Severity: Moderate. Recall number: D-0899-2018.