Sterility Issues Lead to Another Compounding Pharmacy Recall

Two Massachusetts compounding pharmacies have been shut down and a third in California is now recalling some of its drugs due to sterility issues, as state and federal agencies continue to crack down on the industry in the wake of a deadly fungal meningitis outbreak last year.  

On August 23, the FDA announced that Park Pharmacy & Compounding in Irvine, California, was recalling two lots of Methylcobalamin, a form of vitamin B12, and Multirace-5 Concentrate injections due to concerns that the products may not be sterile.

The Park Pharmacy & Compounding recall came just days after the Massachusetts Board of Registration in Pharmacy shut down Medi-Son Solutions in Norwood and CarePro in Quincy due to problems found during inspections.

Both the FDA and Massachusetts health officials are in the midst of a crackdown on compounding pharmacies allegedly employing practices that may make their injection drugs vulnerable to contamination. The crackdown comes after manufacturing problems at a single pharmacy in Massachusetts resulted in an outbreak of fungal infections late last year, which has sickened more than 700 people and killed more than 60.

Following the outbreak, both agencies were accused of dropping the ball on their investigations of the New England Compounding Center (NECC), which has been linked to the fungal meningitis outbreak. The agencies knew for years there were problems that could threaten public health, but failed to act to shut down NECC before the outbreak. The lack of action by both agencies led to finger-pointing and accusations.

The Park Pharmacy recall affects Methylcobalamin 5 mg/ml 30 ml Amber Vials with a lot number of 0613201@1 and an expiration date of 12/10/2013. It also affects one lot of Multitrace-5 Concentrate 10ml Amber Vials with a lot number of 05212013@20 with an expiration date of 11/17/2013. The recalled drugs were sold in June and July in California, Florida, New Mexico, and Indiana directly to customers and physician offices.

The compounding pharmacies targeted by the Massachusetts pharmacy board are sister companies. They are currently undergoing hearings in regards to the cease and desist notices sent last week by the state. The shut-down orders came as the result of surprise inspections in April that revealed a number of violations that could cause a public health risk, according to state agencies. The pharmacies are closed during the hearing process and could permanently lose their pharmacy licenses.

FDA Seeks More Compounding Pharmacy Authority

The FDA is currently trying to push Congress to give it new powers over the compounding pharmacy industruct, which would clarify its authority.

Earlier this month, one compounding pharmacy in Texas, NuVision Pharmacy, defied FDA efforts to have its products recalled. The company failed to cooperate with a request that it recall some drugs which could put the public at risk.

As a result, the FDA issued a warning to all doctors not to use NuVision’s drugs. The clash came after the pharmacy also issued a Methylcobalamin recall; one of the same drugs pulled from the market by Park Pharmacy & Company.

The conflict appears to give credence to recent claims made by FDA officials that the agency needs stronger authority over compounding pharmacies in the wake of the fungal meningitis outbreak that started about a year ago.

The fungal meningitis outbreak was traced back to thousands of contaminated epidural steroid injections distributed by the New England Compounding Center (NECC) in Massachusetts.

In the wake of the outbreak, NECC has filed for bankruptcy and faces a number of fungal meningitis lawsuits. However, reports have suggested that the FDA knew about problems at NECC for years, but did not take action to remove its drugs from the market until after the outbreak had begun, earning criticism from some lawmakers and groups who say it should have taken action.