Mold Risk Leads New Jersey Compounder to Recall All Products

Posted on March 19, 2013

Compounding pharmacies are in the news once again.  Months ago, the presence of mold in products from a Massachusetts-based facility led to fatalities across the country, and the incident prompted lawmakers to take another look at how the operations of compounders are overseen by local and federal officials.  The Food and Drug Administration vowed to strengthen its ability to oversee these companies, which oftentimes act more like drug manufacturers than pharmacies.

Now, the threat of mold in compounder-based products has reared its head again, and only time will tell if it renews fervor to crack down on these entities.  This time, the Tinton Falls, New Jersey-based Med Prep Consulting announced the recall, which affects all products that were compounded and distributed by the company.

The recall comes on the heels of a Connecticut healthcare facility reporting a mold contamination that had compromised the safety of Magnesium Sulfate 2GM in Dextrose 5% in Water, 50ML for Injection.  Five of these 50 ML bags were shown to be impacted, but because the incident prompted concerns about the sterility of all products from the company, the all-encompassing recall was issued.

Thankfully, no injurious incidents have been reported yet in conjunction with these items from Med Prep.  If patients are given a contaminated intravenous medical item, they could suffer from a potentially deadly infection.  Healthcare centers across the country that received the products are being asked to cease patient administration and ship the items back for a refund.  A full list of items is available at the link above.

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