Agency classClass IIOur severity:Severe FDA (Drugs)·D-0958-2018·Announced 2018-07-25

Avella Recalls NORepiNEPHrine 16 Bags Due to Sterility Concerns

Avella of Deer Valley, Inc. is recalling 520 bags of NORepiNEPHrine 16 injection due to potential bag leakage and lack of assurance of sterility.

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 assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Avella of Deer Valley, Inc. Store 38 is recalling 520 bags of NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL). The product is a single-dose bag with a volume of 266 mL. The recall is being conducted due to a lack of assurance of sterility, specifically caused by potential leakage of the bags.

The affected product is identified by the following lot numbers and best-use dates: Lot #4/26/18 0515 83425P with a best-use date of 6/25/2018, and Lot #4/24/18 1332 83425P with a best-use date of 6/23/2018. The NDC number for the product is 42852-834-25.

The recalled product was distributed nationwide in the USA. Healthcare providers and patients should check their inventory for these specific lot numbers and discontinue use if found.

The recalled product

Product: NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
leakage
Affected units: 520

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 (4)

Lot #:4/26/18 0515 83425P
BUD 6/25/2018
4/24/18 1332 83425P
BUD 6/23/2018.

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