Agency classClass IIOur severity:Severe FDA (Drugs)·D-0962-2018·Announced 2018-07-25

Avella Recalls Phenylephrine IV Bags Due to Sterility Concerns

Avella of Deer Valley is recalling 120 bags of Phenylephrine 20 mg IV solution 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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects like leakage that compromise sterility in a drug product.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 120 single-dose bags of Phenylephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL). The product was manufactured by Avella of Houston and distributed nationwide in the USA. The specific lots affected are identified by lot numbers 5/22/18 1012 495-89425P (BUD 7/21/2018) and 6/5/18 0302 495-89425P (BUD 8/4/2018).

The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. This defect could compromise the sterile integrity of the intravenous solution.

Healthcare facilities and patients who have received this product should contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — IV Solution
Hazard: sterility
leakage
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 (4)

Lot #: 5/22/18 1012 495-89425P
BUD 7/21/2018
6/5/18 0302 495-89425P
BUD 8/4/2018. .

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