Med Prep Consulting Recalls Magnesium Sulfate Injection Bags Due to Mold
Med Prep Consulting is recalling 403,883 bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection due to non-sterility and mold contamination.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
Med Prep Consulting, Inc. is recalling 403,883 bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags. The recall is being conducted because the product is non-sterile and contains mold contamination.
The affected product was distributed nationwide to the following states: Delaware, Florida, Illinois, Indiana, Maine, Michigan, New Jersey, Pennsylvania, Texas, and Virginia. All lots of the product are included in this recall.
Healthcare facilities and consumers should stop using the recalled product and contact Med Prep Consulting, Inc. for further instructions or a refund.
The recalled product
- Product
- Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
- Manufacturer
- Med Prep Consulting, Inc.
- Category
- Drug — Injectable Medication
- Affected units
- 403,883
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)
- All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Med Prep Consulting, Inc. 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 2 products in this recall →Related recalls
Same manufacturer · Med Prep Consulting, Inc.
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FDA (Drugs) · 2013-07-31
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