Agency classClass IIOur severity:Severe FDA (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.

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 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: sterility
leakage
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 →

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

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Same hazard · sterility