Advanced Pharma Recalls Subpotent Magnesium Sulfate IV Bags
Advanced Pharma Inc. is recalling 25 bags of Magnesium Sulfate IV solution in Texas due to subpotent product.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 states the agency classification is 'Class I'. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4. Since no deaths are reported, the score is 4 (Severe) rather than 5 (Critical).
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
- 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.
Lot numbers (1)
- Lot: 12/22/17 1422 108-90710P UD: 3/22/2018
Distribution
Distributed in 1 state:
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