The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0964-2018·Announced 2018-07-25

Avella Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

Avella of Deer Valley, Inc. is recalling 225 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 recall is classified as FDA Class II and involves a lack of sterility assurance for an injectable drug, which poses a risk of serious injury or death if administered.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 225 single-dose syringes of ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP. The product is identified by Lot # 5/10/18 1451 89561S and has a beyond-use date of 9/7/2018.

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

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

The recalled product

Product
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Injectable
Hazard
Affected units
225

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 #: 5/10/18 1451 89561S
  • 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 →

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