Agency classClass IIOur severity:Severe FDA (Drugs)·D-0943-2018·Announced 2018-07-25

Avella Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

Avella of Deer Valley is recalling 500 syringes of ephedrine sulfate 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 source text identifies the recall as FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential sterility issues in injectable medications.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 500 single-dose syringes of ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP. The product is identified by NDC 42852-891-61 and Lot # 05/10/18 2011 89161S, with a beyond-use date of 9/7/2018.

The recall was initiated because of a lack of assurance of sterility, specifically due to potential leakage of the bags. The agency has classified this as a Class II recall.

The affected syringes were distributed nationwide in the USA. Healthcare providers and patients should stop using the recalled product and contact the manufacturer or their supplier for further instructions.

The recalled product

Product: ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable Medication
Hazard: sterility
leakage
Affected units: 500

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 #: 05/10/18 2011 89161S
BUD 9/7/2018

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

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Same hazard · sterility