Agency classClass IIOur severity:Severe FDA (Drugs)·D-0947-2018·Announced 2018-07-25

Avella Recalls Heparin Bags Due to Potential Sterility Issues

Avella of Deer Valley is recalling 900 bags of Heparin 12,500 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 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, which corresponds to a Severe severity score (4) under the rubric, as it involves a defect that could cause temporary or medically reversible health consequences.

Plain-English summary

Avella of Deer Valley, Inc. Store 38 is recalling 900 bags of Heparin 12,500 Units in 5% Dextrose (NDC 42852-745-25). The affected product is a single-dose 252.5 mL bag with a best-use date of 8/19/2018. The recall covers specific lots: 138-20181105@65, 138-20181105@64, and 138-20181105@63.

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.

The affected product was distributed nationwide in the USA. Healthcare providers and patients should stop using the recalled product and contact their pharmacy or the recalling firm for further instructions.

The recalled product

Product: HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
leakage
Affected units: 900

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 #: 138-20181105@65
138-20181105@64
138-20181105@63
BUD 8/19/2018.

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

See all →

Severe
Avella Recalls Povidone Iodine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-10-30
Severe
Avella Recalls Bevacizumab Prefilled Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-06-05
Moderate
Avella recalls magnesium sulfate bags with incorrect barcode expiration dates
FDA (Drugs) · 2019-02-20
Moderate
Avella Recalls Labetalol Syringes Due to Incorrect Barcode Expiration Dates
FDA (Drugs) · 2019-02-20
Moderate
Avella recalls magnesium sulfate bags with incorrect barcode expiration dates
FDA (Drugs) · 2019-02-20

Same hazard · sterility