The Recall Desk
CriticalFDA (Drugs)·D-810-2013·Announced 2013-07-31

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard
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

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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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Same hazard · mold contamination

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