Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns
Avella of Deer Valley is recalling 100 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 100 single-dose bags of MAGnesium 4gm in NS 100 mL (NDC 42852-905-10). The product was distributed nationwide in the USA, specifically for Gaston Memorial Hospital. The recall is due to a lack of assurance of sterility caused by potential leakage of the bags.
The affected product is identified by Lot # 5/1/18 0501 548-90510P with a beyond-use date of 7/30/2018. The bags contain 4 gm of Magnesium Sulfate (USP) and 100 mL of 0.9% Sodium Chloride (USP), with a total volume of 108 mL.
Healthcare facilities and consumers should stop using the affected product and contact the recalling firm for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Injectable Solution
- Affected units
- 100
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 # 5/1/18 0501 548-90510P
- BUD 7/30/2018.
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.
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