The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0941-2018·Announced 2018-07-25

Avella Recalls Vancomycin Bags Due to Potential Leakage

Avella of Deer Valley is recalling 1,352 bags of Vancomycin 1.25gm in D5W 250 mL due to potential leakage that compromises 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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are classified as Severe (Score 4). The lack of sterility assurance in an injectable medication represents a significant risk of harm.

Plain-English summary

Avella of Deer Valley, Inc. Store 38 is recalling 1,352 bags of Vancomycin 1.25gm in D5W 250 mL (NDC 42852-617-25). The product is a single-dose bag with a volume of 262 mL. The recall is being conducted because of a lack of assurance of sterility, specifically due to potential leakage of the bags.

The affected lots include 138-20181005@92, 138-20181005@91, and 138-20181005@90 with a best use date of 7/9/2018; lot 138-20181405@78 with a best use date of 7/13/2018; and lot 138-20181605@61 with a best use date of 7/15/2018. The product was distributed nationwide in the USA.

Healthcare providers and patients should stop using the affected product and contact Avella of Deer Valley, Inc. or their local FDA office for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Antibiotic
Hazard
Affected units
1,352

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 (8)

  • Lot # 138-20181005@92
  • 138-20181005@91
  • 138-20181005@90
  • BUD 7/9/2018
  • 138-20181405@78
  • BUD 7/13/2018
  • 138-20181605@61
  • BUD 7/15/2018

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 →

Related recalls

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

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Same hazard · sterility compromise

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