Agency classClass IIOur severity:High FDA (Drugs)·D-0934-2018·Announced 2018-07-25

Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns

Avella of Deer Valley is recalling 240 bags of Heparin 25,000 Units 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medication (Heparin) with a defect (leakage) that compromises sterility, posing a risk of harm, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 240 bags of Heparin 25,000 Units in 5% Dextrose (NDC 42852-729-25). The affected product consists of single-dose 255 mL bags distributed nationwide in the USA. The specific lots involved are 138-20181505@92 with a best-use date of 8/23/2018, and 138-20181605@78 with a best-use date of 8/24/2018.

The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. This defect could compromise the safety of the medication for patients.

Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their medication for the specific lot numbers and best-use dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product: HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
leakage
Affected units: 240

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 # 138-20181505@92
BUD 8/23/2018
138-20181605@78
BUD 8/24/2018

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