Agency classClass IIOur severity:Severe FDA (Drugs)·D-0952-2018·Announced 2018-07-25

Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

Avella of Deer Valley is recalling 175 bags of Magnesium Sulfate in Sodium Chloride 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 explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) and cannot be lower.

Plain-English summary

Avella of Deer Valley, Inc. Store 38 is recalling 175 single-dose bags of MAGnesium 2gm in NS 100 mL. The product is a sterile intravenous solution containing Magnesium Sulfate (USP) and 0.9% Sodium Chloride (USP). The recall was initiated because of a lack of assurance of sterility, specifically due to potential leakage of the bags.

The affected product was distributed nationwide in the USA. The specific lots involved are identified by the following codes: 5/2/18 0318 284-90710P (BUD 7/31/2018), 5/9/18 0502 423-90710P (BUD 8/7/2018), and 5/18/18 0500 284-90710P (BUD 8/16/2018). The product was manufactured for Desert Regional Med Ctr.

Healthcare providers and consumers should check their inventory for these specific lot numbers and discontinue use if found. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10
Manufacturer: Avella of Deer Valley, Inc. Store 38
Category: Drug — IV Solution
Hazard: sterility
leakage
Affected units: 175

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 (6)

Lot #: 5/2/18 0318 284-90710P
BUD 7/31/2018
5/9/18 0502 423-90710P
BUD 8/7/2018
5/18/18 0500 284-90710P
BUD 8/16/2018.

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