Tennessee Drug Supplier Recalls Products After Failing FDA Inspections

By Staff Writer

On April 12, The Tennessean reported on a Nevada-based pharmaceutical company licensed to sell over-the-counter medications in Tennessee who issued a recall of all of their sterile products at the insistence of the Food and Drug Administration (FDA).

The company, Green Valley Drugs, did not pass FDA inspection, and inspectors were even refused full access in one Memphis facility to see if the company was following proper health and safety protocols.

After obtaining a federal court order permitting further inspection, the FDA found employees leaning over processing areas for injectables with exposed facial hair and unsanitary conditions. The inspectors also discovered IV bags being improperly stored and unprotected in a warehouse.

The products recalled contain methylprednisolone acetate, which as you may recall, was the same chemical responsible for the meningitis scare late last year. Last year’s outbreak exposed over 14,000 people in 23 states to fungal meningitis bacteria, and affected an estimated 125 Tennessee citizens, 9 of whom ultimately died from the disease.

(To learn more about the 2012 meningitis scare and the steroid that caused it, read our blog post about the incident.)

The new recall was officially posted on April 11 in a statement by the FDA saying, “Until further notice, healthcare providers should stop using All Lots of Sterile products and return them to the company… Patients who have received any product distributed by Green Valley Drugs and have concerns should contact their healthcare provider.”

In a press release, Green Valley Drugs points out that while no reports of injury or illness have occurred from their products, they are recalling the drugs out of an “abundance of caution,” stating that, “Green Valley Drugs is voluntarily recalling All Lots of Sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.”

Another drug supplier in Bristol, TN, recently issued a minor recall because of sterility issues as well, which put patients at risk of microbial contamination.

Any adverse health conditions resulting from a Green Valley Drug product should be reported to the FDA’s MedWatch Adverse Event Reporting program, either online or through the mail.

If you or someone you know has recently used a Green Valley Drugs product and are experiencing symptoms of fungal meningitis, get an examination by your physician immediately.

For those who are suffering from meningitis caused by a contaminated drug, our medical malpractice attorneys at Gilreath & Associates are standing by to help you and your family get the compensation you deserve. Schedule a free consultation today.

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