Balanced Solutions Compounding Pharmacy Recall: Sterility Problems

Government health officials are continuing to hammer down on compounding pharmacies that could pose serious health risks to the public, resulting in another pharmacy recalling all of its supposedly sterile products due to possible contamination risks.  

On April 17, the FDA announced a recall of all products marked sterile distributed by Balanced Solutions Compounding Pharmacy, LLC, of Lake Mary, Florida.

The company agreed to the recall after FDA investigations identified potential concerns about the quality control processes. According to health regulators, there is no way to assure that products the company claims are sterile are actually free of contaminants.

Balanced Solutions is just the latest in a number of compounding pharmacies that have been forced to enact recalls of products in recent months in the wake of a nationwide fungal meningitis outbreak that is believed to have started at a compounding pharmacy in Massachusetts.

The fungal meningitis outbreak killed more than 50 people and sickened more than 700. It was traced back to epidural steroid injections distributed nationwide by the New England Compounding Center (NECC). Records later revealed that both the FDA and Massachusetts health officials knew there was a problem at the facility for years, but did virtually nothing and allowed it to continue to operate, despite clear signs that NECC was a risk to public health.

NECC faces a growing number of fungal meningitis lawsuits, possible criminal charges and has declared bankruptcy under the weight of its impending legal woes. The pharmacy was shut down in October and recalled all of its products.

Since then, the FDA and state health agencies have been scrutinizing compounding pharmacies nationwide for signs that they are putting out drugs that may put the public at risk. A number of them, like Balanced Solutions, have been forced to recall all of the products they labeled as being sterile.

FDA Facing Criticism

In recent months, the FDA has been criticized for its lack of action leading up to the fungal meningitis outbreak.

Statements made before congress by FDA officials, indicating that the agency needs more regulatory power to do its job, have resulted in skepticism from some lawmakers. They point out that the FDA appears to be doing just fine now that the public is watching how it enforces regulations against compounding pharmacies in response to the outbreak.

The investigations have revealed that many compounding pharmacies have been acting like stealth drug manufacturers, mixing up medications with no federal or state oversight or quality control. Compounding pharmacies are supposed to supply local hospitals with drugs that they cannot get from the manufacturer on a per-prescription basis. However, NECC shipped 17,000 vials of its epidural steroid injections nationwide and even employed sales representatives to push its products.

Even though Balance Solutions was a Florida-based compounding pharmacy, its drugs were shipped nationwide. A complete list of the products affected by the recall are available in the Balanced Solutions recall notice.

Customers with questions can contact Balanced Solutions at (877) 306-0008 or email the company at pharmacist@bshrx.com.