The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0932-2018·Announced 2018-07-25

Avella Recalls Epinephrine Bags Due to Potential Leakage and Sterility Concerns

Avella of Deer Valley, Inc. is recalling 700 bags of Epinephrine (USP) 4 mg 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 700 bags of EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL single-dose bags. The recall is being conducted because of a lack of assurance of sterility, specifically due to potential leakage of the bags.

The affected product is identified by NDC 42852-823-25. The specific lots involved are Lot # 4/30/18 0512 2-82325P with a beyond-use date of 6/14/2018, and Lot # 5/22/18 1238 82325P with a beyond-use date of 7/6/2018. The product was distributed nationwide in the USA.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their supplier for further instructions.

The recalled product

Product
EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — IV Solution
Hazard
Affected units
700

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 # 4/30/18 0512 2-82325P
  • BUD 6/14/2018
  • 5/22/18 1238 82325P
  • BUD 7/6/2018.

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 →

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