TDH Issues Warning about Possible Unsafe Medications from Wellness Store Pharmacy in Cleveland, TN

NASHVILLE — The Tennessee Department of Health is urging people who received certain injectable medications produced by the Wellness Store Compounding Pharmacy, located at 3555 Keith Street NW in Cleveland, Tenn., to not use those products. This action comes after an investigation by the Tennessee Board of Pharmacy revealed issues that could affect the effectiveness and safety of some materials produced by the pharmacy.

The compounded injectable medications were small in quantity, distribution was confined to a limited area, and TDH and the Board of Pharmacy are not aware at this time of any patients being harmed by any medications provided by the Wellness Store Compounding Pharmacy. However, this warning is being issued out of an abundance of caution so any patient or clinician who has received these injectable medications produced by the Wellness Store Compounding Pharmacy in Cleveland should not use those products and, if symptoms develop, should seek appropriate attention.

Symptoms may include pain, swelling or redness at or near an injection site. Concerned patients should contact their healthcare provider and mention this notice. Unused medication should not be thrown away; it should be collected by the Tennessee Department of Health. Arrangements can be made by calling 615-741-2718.

Violations found during the inspection process included:  use of outdated, deteriorated or otherwise unsafe ingredients; unsupervised production of sterile compounded products; intentional falsification of records; and unlawful dispensing of controlled substance prescriptions by the pharmacist in charge. The compounded drugs include prescription eye drops and both injectable and implantable products, with most being provided to clinicians’ offices. Some sterile medications may have been provided directly to other customers of the pharmacy. 

The pharmacy was instructed to cease sterile compounding Aug. 28 and complied; licenses for the pharmacy and pharmacist Robin Terrero, DPH were summarily suspended Sept. 10; and the Board of Pharmacy upheld those suspensions Sept. 18. The Tennessee Department of Health has obtained invoices for sterile compounded products distributed by the pharmacy and is working with clinicians to ensure the materials are not used or discarded.

The clinics known to have received injectable medications from Wellness Store Compounding Pharmacy in Cleveland, Tenn. after Jan. 1, 2014 are:

Associates in Spine and Joint Medicine, Cleveland, Tenn.

Cleveland Medical Associates, Cleveland, Tenn.

East Tennessee Vein Clinic, Knoxville, Tenn.

Hollywood Body Spa, Athens, Tenn.

Internal Medicine Group, Cleveland, Tenn.

Kennedy Clinic, Ooltewah, Tenn.

Lynn Garden Weight Loss, Kingsport, Tenn.

Premier Weight Management, LaFollete, Tenn.

Voytik Center for Orthopedics, Cleveland, Tenn.

The injectable medications in question include:  steroids, vitamin B12, amino acids such as those containing adenosine and hormones such as beta HCG.

“Our inspector’s findings, coupled with concerns about the pharmacy’s outreach efforts, prompt us to notify the public of potential health risks,” said Reginald Dilliard, DPH, executive director of the Tennessee Board of Pharmacy. “We lack confidence in the records of the Wellness Store Compounding Pharmacy in Cleveland and while no medical complications have been detected, out of an abundance of caution, we are notifying the public of the potential problems with some medications from this business.”