Agency classClass IIOur severity:Severe FDA (Drugs)·D-0960-2018·Announced 2018-07-25

Avella Recalls Norepinephrine Bags Due to Potential Leakage and Sterility Concerns

Avella of Deer Valley is recalling 2,280 bags of Norepinephrine Bitartrate in 5% Dextrose due to potential bag leakage and lack of sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or death if contaminated product is administered.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 2,280 bags of NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL). The product is a single-dose bag with a concentration of 16 mcg/mL and a volume of 254 mL. The recall is being conducted because of a lack of assurance of sterility, specifically due to potential leakage of the bags.

The affected product was distributed nationwide in the USA. The specific lots involved are: Lot # 4/30/18 2471 80725P with a beyond-use date of 6/29/2018; Lot # 5/1/18 1240 80725P with a beyond-use date of 6/30/2018; and Lot # 5/8/18 1111 80725P with a beyond-use date of 7/7/2018. The NDC number for the product is 42852-807-25.

Healthcare providers and facilities should stop using the affected lots and contact the recalling firm for instructions on return or disposal. Patients who have received this medication should contact their healthcare provider if they have any concerns or experience adverse effects.

The recalled product

Product: NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
leakage
Affected units: 2,280

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 (5)

Lot #: 4/30/18 2471 80725P
BUD 6/29/2018
5/1/18 1240 80725P
BUD 6/30/2018
5/8/18 1111 80725P BUD 7/7/2018.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 recalled by Avella of Deer Valley, Inc. Store 38 under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Same manufacturer · Avella of Deer Valley, Inc. Store 38

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Same hazard · sterility