Agency classClass IIOur severity:Severe FDA (Drugs)·D-0940-2018·Announced 2018-07-25

Avella Recalls Phenylephrine Bags Due to Potential Leakage

Avella of Deer Valley is recalling 200 bags of Phenylephrine 40 mg 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 involves a sterile injectable drug with a risk of contamination due to leakage, which aligns with the 'Severe' criteria for significant injury risk or Class II classifications involving serious health hazards.

Plain-English summary

Avella of Deer Valley, Inc. is recalling 200 single-dose bags of Phenylephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL). The product is identified by NDC 42852-893-25, Lot # 5/23/18 3812 89325P, and has a beyond-use date of August 6, 2018.

The recall was initiated due to a lack of assurance of sterility, specifically caused by potential leakage of the bags. This defect poses a risk of contamination to the sterile injectable solution.

The affected product was distributed nationwide in the USA. Healthcare providers and patients should discontinue use of the recalled product and contact the manufacturer for further instructions.

The recalled product

Product: PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — Injectable
Hazard: sterility
leakage
Affected units: 200

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 (2)

Lot # 5/23/18 3812 89325P
BUD 8/6/2018.

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