PlainRecalls
FDA Drug Low Class III Terminated

Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05

Reported: December 19, 2018 Initiated: November 21, 2018 #D-0295-2019

Product Description

Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05

Reason for Recall

Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Details

Recalling Firm
QuVa Pharma, Inc.
Units Affected
168 bags
Distribution
CA only
Location
Sugar Land, TX

Frequently Asked Questions

What product was recalled?
Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05. Recalled by QuVa Pharma, Inc.. Units affected: 168 bags.
Why was this product recalled?
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Which agency issued this recall?
This recall was issued by the FDA Drug on December 19, 2018. Severity: Low. Recall number: D-0295-2019.