Agency classClass IIOur severity:Severe FDA (Drugs)·D-0133-2019·Announced 2018-11-07

Avella Recalls Hydromorphone Bags Due to Sterility Assurance Concerns

Avella of Deer Valley, Inc. is recalling 360 bags of Hydromorphone in NS due to a lack of assurance of sterility. The product was distributed nationwide.

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, and the hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Avella of Deer Valley, Inc. Store 38 is recalling 360 bags of Hydromorphone (0.2 mg/mL) in NS 100 mL Bag. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is prescription-only and was distributed nationwide in the United States. The specific lot number is 8/27/18 0215 22110P, with an expiration date of 12/10/2018.

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

The recalled product

Product: Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 360

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 (2)

Lot # 8/27/18 0215 22110P
Exp 12/10/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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

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Same hazard · sterility