Advanced Pharma Recalls Subpotent Magnesium Sulfate IV Bags

Plain-English summary

Advanced Pharma Inc. has voluntarily recalled 25 bags of Magnesium Sulfate (USP) 0.9% Sodium Chloride (USP) in 100 mL sterile single-dose bags. The product, identified by NDC 42852-907-10, was distributed in Texas. The recall was initiated on January 5, 2018, and was classified as Class I by the FDA.

The reason for the recall is that the product was found to be subpotent, meaning it did not contain the full labeled amount of the active ingredient. The specific lot affected is 12/22/17 1422 108-90710P, with a use-by date of March 22, 2018. The recall status is currently terminated.

Healthcare providers and patients in Texas who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this as a Class I recall, which is the most serious type of recall.

The recalled product

Product

MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10

Manufacturer

Advanced Pharma Inc.

Category

Drug — IV Solution

Hazard

• subpotent

Affected units

25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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