Contamination spurs drug recall

12:37 PM, Oct 25, 2013   |    comments
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(Christopher Behnan, Livingston County Daily Press & Argus)--A South Lyon compounding pharmacy is taking "an abundance of caution" in recalling 98 unexpired sterile medications after contamination was discovered in one of its products at a Michigan hospital, the facility's spokesman said.

Specialty Medicine Compounding Pharmacy on Saturday learned that particulate matter of some kind was discovered in vials of a dextrose-based intravenous solution dispensed to a Henry Ford Health System hospital.

No illnesses have been reported from the hospital that received the contaminated product, which has been removed. Testing is underway to determine what the contamination was.

"Very little is definitive right now. We don't know what the particulate is," said David Ball, spokesman for Specialty Medicine Compounding Pharmacy.

"We don't know how or where it developed," Ball added.

The compounded products - two or more medicines combined for individual purposes - that were recalled were purchased by about 80 people mostly in southeastern Michigan between July 1 and Saturday, Ball said.

The recalled products include 79 products for humans and 19 products for pets.

Those who purchased the recalled products are being notified by mail and will be reimbursed for unused medications, Ball said. The company is sending customers postage-paid containers to return the products in.

Unused medication can also be returned in person at the pharmacy, 350 S. Lafayette St. in downtown South Lyon, east of the Livingston County border.

The company is not recalling its nonsterile products, such as creams, gels and throat lozenges.

Those who have products that have been recalled should stop using them and contact the pharmacy to arrange for return of unused medication. They should also contact their doctor if they experience health problems that could be linked to use of the medications.

Specialty Medicine Compounding Pharmacy, which has 12 employees, is processing its first recall.

The pharmacy was established in 1999 as South Lyon Family Pharmacy and in 2002 became Specialty Medicine Compounding Pharmacy.

"We are committed to working cooperatively with state and federal health officials to resolve this issue as quickly as possible," said Kenny Walkup, R.Ph, president of Specialty Medicine Compounding Pharmacy. "We apologize for the inconvenience that this voluntary recall may cause our valued customers, but their safety is paramount."

It only produces compounded medicines for Michigan residents, and is an example of the smaller compounding pharmacies that some lawmakers hope to hold harmless as they write regulations for larger compounders.

The facility is accredited through the Pharmacy Compounding Accreditation Board, a national professional association that accredits only a select number of compounders, Ball said.

"This pharmacy operates at the highest standards of its profession. Oversight and regulation are something that are generally welcomed by our pharmacies operating at that level," he said.

Congress and the state Legislature hope to create new requirements for larger compounding pharmacies, such as the former New England Compounding Center that produced tainted steroid injections linked to last year's nationwide fungal meningitis outbreak.

That outbreak resulted in 750 infections nationwide and 64 deaths. In Michigan, there were 264 infections that resulted in 19 deaths.

Eight of those deaths were of Livingston County residents.

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