Florida Department of Health Restricts Permit for Village Fertility; Florida Inspectors Receive Comprehensive Training

March 5, 2012

Contact: DOH Communications
(850) 245-4111

FLORIDA DEPARTMENT OF HEALTH RESTRICTS PERMIT FOR VILLAGE FERTILITY
~Pharmacy restricted from shipping or dispensing in Florida~

TALLAHASSEE- On February 26, 2013 the Florida Department of Health executed a voluntary agreement to restrict practice with Village Fertility Pharmacy in Waltham, MA. The state of Massachusetts issued a Cease and Desist order and a notice of Quarantine against the pharmacy on February 20 after possible contamination of vials of progesterone, a hormone used to aid in fertility. Village Fertility is a sterile compounding pharmacy which also holds a non-resident pharmacy permit in Florida.

Black particulate matter was observed in 10 ml multi-use vials of the intramuscular progesterone oleate. Particulates have not been observed in other products manufactured by the company, however, the Massachusetts Board of Pharmacy has advised Village Fertility to recall all products based on the common production involved. Vials containing contaminant have been sent for testing to a Food and Drug Administration lab and after five days of culture there has been no growth of any biological material. Final results will be available March 7, 2013. There have been no reported adverse reactions to these products.

The notice issued by the state of Massachusetts requires Village Fertility to cease and desist all sterile compounding, quarantine all compounded sterile products on its premises and notify all patients who received certain vials. The voluntary agreement to restrict practice instructs Village Fertility Pharmacy to immediately cease compounding medications for Florida residents and to cease dispensing or shipping medications it has previously compounded to Florida residents.

There were 95 patients in Florida who received the recalled compounded products, leuprolide acetate and progesterone oleate. The Department of Health is proactively reaching out to recipients of these products to insure they were in fact notified by Village Fertility and that they are no longer in possession of any of the recalled products.

The Department remains vigilant to assure the safety of Florida’s drug supply. The Department’s inspectors receive comprehensive training in sterile compounding and carry out a prioritized inspection schedule based upon the results of a mandatory pharmacy compounding survey. That survey resulted in 55 complaints being opened and two emergency suspension orders being issued. The Florida Board of Pharmacy is also conducting a series of workshops to amend its rules governing the practice of compounding. The next workshop is scheduled for March 22, 2013 in Orlando.

Follow us on Twitter at @HealthyFla and on Facebook. For news story ideas, interviews, videos and more from DOH Communications visit the DOH Online Newsroom.

source found here

Feb 25, 2013, 11:03am EST: Recall from Village Fertility Pharmacy--6 products over three years

Waltham, Mass.-based Village Fertility Pharmacy has issued a voluntary recall of several compounded products, after a foreign substance was detected in a small percentage of two lots of the fertility drug progesterone. The pharmacy said it contacted the Massachusetts Board of Pharmacy immediately after discovering the particulate matter.

The recall includes six different products shipped over the past three months. They include five progesterone products and one other medication, Leuprolide. More testing is being conducted and results will be released in the coming days.

Related: Compounding crackdown hurting patients (premium content).

“We are working cooperatively with all government agencies and are awaiting the results of the investigation,” Village Fertility Pharmacy president Stuart Levine said in a statement. “While no patients have reported any adverse effects, we believe the prudent course is to recall all of these medications.”

The recall includes the following products:

* Progesterone Injection Cottonseed Oil 50 MG/ML

* Progesterone Injection Olive Oil 50 MG/ML, 100 MG/ML

* Progesterone Injection Sesame Oil 50 MG/ML, 100 MG/ML

* Progesterone Injection Ethyl Oleate 50 MG/ML, 100 MG/ML

* Hydroxy Progesterone Caproate 250 MG/ML

* Compounded Leuprolide Acetate 1MG/.2ML

Progesterone is a hormone that supports pregnancy and it is compounded in different solutions to accommodate patients’ various needs. Leuprolide suppresses natural ovulation.

Village Fertility Pharmacy said that only 5 percent of its overall business comes from compounded products.

source found here

ABC40 Alert: Drug Recalled by Mass. Compounding Pharmacy--Huge: 39 states and approximately 2100 patients affected

WALTHAM, Mass. (ABC) — Another Massachusetts pharmacy is in trouble.

Village fertility pharmacy in Waltham, Mass. is conducting a voluntary recall of compounded medications for women who are undergoing in vitro fertilization treatment.

The company issuing the recall after something was found floating in a vial. Massachusetts board of pharmacy ordered the company to cease and desist all sterile compounding on February 20.

Pharmacy officials say the medications were shipped to 39 states to approximately 2,100  patients. According to the pharmacy, none of their patients have reported any adverse effects.

 

Source found here

BREAKING NEWS: Massachusetts Specialty Pharmacy Announces Voluntary Recall

February 24, 2013 10:30 AM Eastern Time 

WALTHAM, Mass.--(BUSINESS WIRE)--Village Fertility Pharmacy is conducting a voluntary recall of compounded medications shipped over the past three months. The recall resulted after particulate was discovered in a small percentage of two lots of Progesterone. Immediately upon learning of the situation, Village contacted the Massachusetts Board of Pharmacy.

“We are working cooperatively with all government agencies and are awaiting the results of the investigation”

After an initial investigation, Village and the Massachusetts Board of Pharmacy decided to expand the recall to include one other medication, Leuprolide. More testing is being conducted and results will be released in the coming days.

“We are working cooperatively with all government agencies and are awaiting the results of the investigation,” according to Stuart Levine, president of Village Fertility Pharmacy. “While no patients have reported any adverse effects, we believe the prudent course is to recall all of these medications.”

The recall includes:

• Progesterone Injection Cottonseed Oil 50 MG/ML
• Progesterone Injection Olive Oil 50 MG/ML, 100 MG/ML
• Progesterone Injection Sesame Oil 50 MG/ML, 100 MG/ML
• Progesterone Injection Ethyl Oleate 50 MG/ML, 100 MG/ML
• Hydroxy Progesterone Caproate 250 MG/ML
• Compounded Leuprolide Acetate 1MG/.2ML

Progesterone is a hormone that supports gestation. It is compounded in different solutions to accommodate patients’ various needs. Leuprolide suppresses natural ovulation.

Village Fertility Pharmacy is a pharmacist-owned and operated specialty fertility pharmacy dedicated to providing exceptional service and educational resources to fertility patients and clinics. Compounding represents five percent of the company’s total work.

Patients with questions can call the Village Recall Hotline at 1-888-965-5813.

Contacts

For Village Fertility Pharmacy
Matt Ellis, 617-278-6560
matt@ballcg.com