The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0963-2018·Announced 2018-07-25

Avella Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

Avella of Deer Valley is recalling 10,500 ephedrine sulfate syringes nationwide 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, which corresponds to a Severe severity score under the rubric for significant injury risks or hospitalization reports.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 10,500 single-dose syringes of ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP. The product is identified by NDC 42852-805-67 and was distributed nationwide in the United States.

The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. The affected lots include those with expiration dates of July 3, 2018, August 28, 2018, and September 7, 2018.

Consumers and healthcare providers should stop using the affected product and contact Avella of Deer Valley, Inc. for further instructions or a refund.

The recalled product

Product
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Injectable Medication
Hazard
Affected units
10,500

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 (9)

  • Lot #: 3/5/18 6702 80567S
  • 3/5/18 2119 80567S
  • BUD 7/3/2018
  • 4/30/18 3701 80567S
  • BUD 8/28/2018
  • 5/10/18 3333 80567S
  • 5/10/18 2222 80567S
  • 5/10/18 1111 80567S
  • 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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