The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →