The Recall Desk
SevereFDA (Drugs)·D-0933-2018·Announced 2018-07-25

Avella Recalls Fentanyl Syringes Due to Potential Leakage and Sterility Concerns

Avella of Deer Valley is recalling 120 fentanyl syringes due to potential bag leakage and lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 assurance of sterility in a parenteral medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 120 single-dose syringes of fentanyl (10 mcg per mL) in 0.95 Sodium Chloride, USP. The product was prepared for Hunt Regional Medical Center by Advanced Pharma. The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags.

The affected product is identified by NDC 15082-210-70. Specific lot numbers and beyond-use dates are listed in the recall documentation, including lots from May and June 2018. The distribution pattern is listed as nationwide in the USA, though the product was prepared for a specific medical center.

Consumers and healthcare providers should check their inventory for the specific lot numbers and beyond-use dates listed in the official recall notice. If the product is found, it should be quarantined and returned to the supplier or destroyed according to local regulations. Patients who have received this medication should consult their healthcare provider if they have concerns about the sterility of the product.

The recalled product

Product
fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Injectable Medication
Hazard
Affected units
120

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 (8)

  • Lot # 5/3/18 0317 142-21070S
  • BUD 8/1/2018
  • 5/10/18 0512 144-21070S
  • BUD 8/8/2018
  • 6/1/18 0305 142-21070S
  • BUD 8/30/2018
  • 6/4/18 0505 252-21070S
  • BUD 9/2/2018.

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 →

Related recalls

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

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Same hazard · sterility

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