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Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Comp...

FDA Recall #D-0295-2019 — Class III — November 21, 2018

Recall #D-0295-2019 Date: November 21, 2018 Classification: Class III Status: Terminated

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

Recalling Firm

QuVa Pharma, Inc. — Sugar Land, TX

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

168 bags

Distribution

CA only

Code Information

Lot #:10016014 Exp. 01/06/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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