The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0295-2019·Announced 2018-12-19

QuVa Pharma Recalls Norepinephrine Injection Bags Due to Incorrect Excipient

QuVa Pharma is recalling 168 bags of Norepinephrine Injection compounded in 5% Dextrose instead of 0.9% Sodium Chloride. The product was distributed in California.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which typically corresponds to a severity score of 1 or 2. Given the potential for clinical impact from an incorrect excipient in a compounded medication, a score of 2 (Moderate) is appropriate as it represents a minor labeling or formulation error that is unlikely to cause adverse health consequences but warrants precautionary action.

Plain-English summary

QuVa Pharma, Inc. is recalling 168 bags of Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag. The recall is due to the product being compounded in 250 mL 5% Dextrose instead of the intended 0.9% Sodium Chloride solution.

The affected product is identified by Lot #10016014 with an expiration date of 01/06/2019. The product code is 70092-9035-05. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The product was distributed in California. Consumers and healthcare providers should stop using the affected product and contact QuVa Pharma or their healthcare provider for further instructions.

The recalled product

Product
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
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Compounded Medication
Hazard
Affected units
168

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #:10016014 Exp. 01/06/2019

Distribution

Distributed in 1 state:

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