MedPrep Compounding Pharmacy Recall Issued For Mold Contamination

Mold contamination has led to a recall of all mixed drugs sent out by a New Jersey compounding pharmacy, as state and federal health officials continue to crackdown in the wake of a nationwide fungal meningitis outbreak. 

A Med Prep Consulting Inc. compounded drug recall was announced on March 17, affecting every product the Tinton Falls, New Jersey pharmacy has distributed.

The recall came after a Connecticut hospital found mold in bags of its magnesium sulfate intravenous solution.

Similar Contamination Blamed for Meningitis Outbreak

Late last year, a nationwide outbreak of fungal meningitis, which sickened more than 700 people and killed at least 48, was linked to contaminated epidural steroid injections distributed by a single compounding pharmacy in Massachusetts.

The New England Compounding Center (NECC) issued a similar recall for all of it’s mixed drugs in October 2012, after fungal contamination was identified.

This new recall affects every product made by Med Prep Consulting, but the drugs that were contaminated with mold were 50 ml bags of magnesium sulfate 2gm in dextrose 5% in water, 50ml for injection. They were uniquely compounded for the Connecticut hospital that discovered the problem.

The recall is the latest effect of increased scrutiny of compounding pharmacies nationwide, and officials in several states have found problems at numerous facilities that appears to only fuel concerns and a growing push for new regulations.

Illegal Distribution a Major Concern

One of the biggest concerns with the compounding pharmacy industry has been the widespread distribution of drugs. In addition, a lack of coordinated oversight has been identified between federal and state agencies that regulate compounding pharmacies.

Compounding pharmacies are supposed to create custom drugs for local hospitals on a per-prescription basis when that patient cannot acquire the drug from a drug manufacturer. However, in the case of NECC and some others that have been investigated since the outbreak, some compounding pharmacies have been acting like stealth drug manufacturing companies that operate without FDA oversight.

In the case of NECC, it distributed 17,000 vials of its epidural steroid injections to hospitals and pain clinics nationwide, and the U.S. Centers for Disease Control and Prevention (CDC) estimates those shots were given to about 14,000 patients across the country.

NECC lost its license and faces criminal probes both because of its failure to sterilize its drugs properly, and because of its distribution practices, which were seen as a violation of its compounding pharmacy license.

The FDA, Massachusetts, Florida, Iowa and other states have begun surprise inspections of compounding pharmacies in recent months. The FDA cited four pharmacies for violations earlier this month. Earlier this year, the Massachusetts Department of Public Health ordered 11 compounding pharmacies to partially or completely shut down operations due to violations. Another 21 received citations. Iowa is in the process of inspecting 80 pharmacies that supply drugs to its state, including some in other states. It has already issued citations against five compounding pharmacies. Those charges include allegations of unlawful drug manufacturing.

NECC faces a growing number of fungal meningitis lawsuits following the outbreak, and declared bankruptcy late last year under the weight of its legal troubles.