The Recall Desk
SevereFDA (Drugs)·D-0931-2018·Announced 2018-07-25

Avella Recalls Epinephrine Bags Due to Potential Leakage and Sterility Concerns

Avella of Deer Valley is recalling 420 bags of Epinephrine 4 mg in 5% Dextrose due to potential leakage that compromises 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 an injectable medication, which poses a significant risk of serious injury or death if administered.

Plain-English summary

Avella of Deer Valley, Inc. Store 38 is recalling 420 single-dose bags of EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL. The product was manufactured by Advanced Pharma and distributed nationwide in the USA for Peninsular Regional Medical Center.

The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. The affected lots have expiration dates ranging from June 18, 2018, to July 17, 2018.

Healthcare facilities and consumers should stop using the affected product immediately and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.
Manufacturer
Avella of Deer Valley, Inc. Store 38
Category
Drug — Injectable
Hazard
Affected units
420

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 (20)

  • Lot # 5/4/18 0300 58-85525P
  • BUD 6/18/2018
  • 5/10/18 1435 262-85525P
  • 5/10/18 1127 558-85525P
  • BUD 6/24/2018
  • 5/11/18 1327 457-85525P
  • BUD 6/25/2018
  • 5/14/18 0302 295-85525P
  • BUD 6/28/2018
  • 5/17/18 0500 558-85525P
  • BUD 7/1/2018
  • 5/24/18 1005 57-85525P
  • 5/24/18 1328 295-85525P
  • BUD 7/7/2018
  • 5/25/18 0302 295-85525P
  • BUD 7/9/2018
  • 5/30/18 0936 262-85525P
  • BUD 7/14/2018
  • 5/31/18 0805 558-85525P
  • BUD 7/17/2018.

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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