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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

PharMEDium Services Initiates Nationwide Magnesium Sulfate Solution Recall of All 50 ml Admixtures of MgSO4 in 5% Dextrose Because of a Potential Lack of Sterility Assurance

Contact:
PharMEDium Services
1-847-457-2300

FOR IMMEDIATE RELEASE -- Houston, TX -- April 8, 2005 -- PharMEDium Services is recalling all strengths of 50 ml admixtures of Magnesium Sulfate in 5% Dextrose solution because of a potential lack of sterility assurance for these products. In addition, effective today, the company is voluntarily ceasing production and distribution of this product until it can determine and correct the source of this problem.

Two previously distributed lots of this product have been associated with outbreaks of Serratia marcescens infection which can potentially cause serious or life-threatening conditions in patients (particularly among the immune-compromised).

The products subject to recall are those labeled under the following Service Codes:

  • 2K2410
  • 2K2411
  • 2K2412
  • 2K2413
  • 2K2419

These products were manufactured by PharMEDium Services of Houston, Texas and were distributed to several hospitals around the country.

On March 18, 2005, FDA issued a nationwide alert regarding PharMEDium Services Magnesium Sulfate 1 gram in 50mL D5W (piggyback) IV solution, lot number 100504900049 and expiration date 4/4/05 after it was associated with five cases of Serratia marcescens infection in a hospital in New Jersey.

The company is working with FDA, the U.S. Centers for Disease Control and Prevention, and other public health authorities. Hospitals with questions may contact the Company at 1 847 457 2300.

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