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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

Apr 8, 2005 | www.fda.gov

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.


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