Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service

Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To see the recall click here.

Recall Based on FDA Findings of Fungal Growth in Pharmacy’s Clean Room.

The recall was apparently prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.

Franck’s Pharmacy Urges Physicians to Assist in Recall Efforts.

Franck’s Pharmacy is seeking […]

By |2024-03-14T10:00:31-04:00June 1, 2018|Categories: In the News, Pharmacy, The Health Law Firm Blog|Tags: , , , , , , , , , , |Comments Off on Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service

Franck’s Pharmacy Closes; Compounding Lab is Now Wells Pharmacy Network

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

July 31, 2012, marked the end of an era for Franck’s Pharmacy in Ocala, Florida, as the retail location closed its doors for good. According to an Ocala Star-Banner article, in July 2012, Franck’s Compounding Lab, which was one of the largest compounding labs in the country, was bought by Wells Pharmacy Network. The deal included Franck’s Lifestyles, which sells supplements and wellness products, but did not include the retail pharmacy location.

Click here to see the official press release from Wells Pharmacy Network.

Closed Pharmacy Comes After a U.S. Food and Drug Administration (FDA) Finding of Fungal Growth in Pharmacy’s Clean Room.

In May of 2012, Franck’s Pharmacy Inc., issued a recall for its compounded prescriptions. The prescriptions impacted by this recall included all sterile human and […]

New England Compounding Pharmacy Linked to Meningitis Outbreak Suspected of Violated License

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The compounding pharmacy behind the meningitis outbreak was allegedly not following the requirements of its state license, according to the Massachusetts Department of Health (DOH) in a released statement on October 10, 2012.

To read the entire statement from the Massachusetts DOH, click here.

The New England Compounding Center (NECC) shipped more than 17,000 vials of a steroid to pain clinics in 23 states, including Florida. The Centers for Disease Control and Prevention (CDC) is now reporting 214 cases of meningitis and 15 deaths associated with the fungal infection. NECC has surrendered its license and has recalled all medications. To see a blog I previously wrote about the recall and compounding facility shutting […]

Boca Raton Compounding Pharmacy Shuts Its Doors After Receiving an Emergency Suspension Order

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On October 26, 2012, the Florida Department of Health (DOH) issued an emergency suspension order (ESO) against a Boca Raton compounding pharmacy, according to a number of sources. The DOH in a press release called the conditions in the pharmacy so “deplorable” that nothing short of immediately shutting down the pharmacy would suffice.

Click here to read the press release from the DOH.

Rodent Feces, Dead Bugs and a Sink Full of Dirty Water all Found at Compounding Pharmacy.

On October 12, 2012, a state inspector arrived at the Boca Raton compounding pharmacy for an inspection. According to an article on Health News Florida, rodent feces, dead bugs and a sink full of dirty water were discovered. A […]

Meningitis Cases in Florida Continue to Rise – Doctors Getting Sued

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Department of Health (DOH) confirmed another case of fungal meningitis in Florida on November 19, 2012. A 56-year-old man allegedly received a contaminated steroid injection at Florida Pain Clinic in Marion County, Florida. This brings the state’s total number of fungal meningitis cases up to 24, including three deaths.

To read the entire press release from the Florida DOH, click here.

Meningitis Numbers Around the U.S. 

As of November 19, 2012, the Florida DOH reported the number of fungal meningitis cases nationwide is up to 480 with 33 deaths in 19 states.

The meningitis outbreak is reportedly linked to contaminated steroids made at the New England Compounding Center (NECC) in Framingham, Massachusetts, which […]

Florida Pharmacy Allegedly the Cause of Eye Infection Outbreak

The Centers for Disease Control (CDC) has allegedly traced a rare fungal infection to an Ocala pharmacy, according to media reports. As reported, Franck’s Compounding Lab is believed to be at least partially responsible for spreading a rare fungal eye infection to over 30 patients across the U.S.

The CDC reports that eye drops and injections traced back to the lab caused the infections. These ophthalmic products contained multiple fungal and bacterial species, according to the CDC. The products have now been recalled, but were in use for over a year before the recall. The CDC has also issued a warning to avoid any product labeled sterile from Franck’s.

The patients impacted by the contaminated products had all undergone some type of eye procedure in which the Franck’s products were used. 23 patients have allegedly suffered some vision loss as a result of the infection.

The Florida Department of Health (DOH) has […]

Negligence Will Determine the Success or Failure of the Meningitis Lawsuits Against Doctors and Clinics

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The victims and survivors of the meningitis outbreak are now filing lawsuits against the physicians and clinics that administered the tainted steroids. According to an article in The Tennessean, on January 29, 2013, a husband who lost his wife to fungal meningitis filed the first lawsuit against a Nashville outpatient clinic. It’s believed hundreds of people were injected at the same clinic with the tainted steroids. The man is now seeking $12.5 million in damages.

Click here to read the entire article from The Tennessean.

This lawsuit is just one in what is expected to be a series of lawsuits, in not just Tennessee, but across the country.

Compounding Pharmacy Allegedly Behind the Meningitis Outbreak is Out of Business.

The meningitis outbreak was at a peak in […]

Florida Department of Health (DOH) Shuts Down Boca Raton Compounding Pharmacy

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On October 26, 2012, the Florida Department of Health (DOH) issued an emergency suspension order (ESO) against a Boca Raton compounding pharmacy, according to a number of sources. The DOH in a press release called the conditions in the pharmacy so “deplorable” that nothing short of immediately shutting down the pharmacy would suffice.

Click here to read the press release from the DOH.

State Inspector Finds Feces, Bugs and Much More in Compounding Pharmacy.

On October 12, 2012, a state inspector arrived at the Boca Raton compounding pharmacy for an inspection. According to an article on Health News Florida, rodent feces, dead bugs and a sink full of dirty water were discovered. A film of powder covered surfaces in the […]

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