FDA recalls some drugs from closed Davie plant

PharmaTech vacated manufacturing plant

Pharmaceutical firm PharmaTech vacated its premises in June. The products, distributed through Leader Brand, Major Pharmaceuticals and Rugby Laboratories, may be contaminated by bacteria, the FDA said in its recall.

DAVIE — All liquid drug products manufactured by Davie-based PharmaTech have been recalled due to the possibility they might be contaminated and cause severe patient infection, the Federal Drug Administration announced.

Meanwhile, after the FDA criticized the company’s quality control process in a May inspection report, PharmaTech vacated its Davie facility in June, a town spokesman said. The company’s website is gone and its phone number disconnected.

The products, distributed through Leader Brand, Major Pharmaceuticals and Rugby Laboratories, are possibly contaminated by the Burkholderia cepacia bacteria, the FDA said in its recall notice.

Testing of PharmaTech’s oral liquid docusate detected a strain of the bacteria linked to recent patient infections, the notice said.

Rugby Laboratories issued a voluntary recall on Aug. 3 of two oral liquid docusate products, Diocto Syrup and Diocto Liquid, which are used to treat and prevent constipation. On Thursday, the recall was expanded to all liquid products made by PharmaTech LLC.

Drugs and dietary supplements made by PharmaTech for use in infants and children might be infected as well, the FDA said.

The recalled products were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies, the FDA said. Consumers who believe they have experienced adverse reactions from any of the products should report them at fda.or/medwatch/report.htm or call 1-800-332-1088 to request a reporting form.

Consumers, pharmacies and healthcare facilities that have the recalled products on hand “should stop using and dispensing them immediately,” the FDA notice said.

Because PharmaTech’s name might not be identified on the label of the liquid products, the FDA advises health care facilities and pharmacies that think they might have them to check with their supplier. Consumers are advised to contact their health care professional.

While the b. cepacia bacteria causes little medical risk to healthy people, it can cause severe patient infection, including serious respiratory infections especially in patients with cystic fibrosis, according to the Centers for Disease Control and Prevention.

The recall is the third in 10 months for PharmaTech. In July 2016, the FDA warned patients and professionals not to use liquid docusate manufactured at the company’s Davie facility after the CDC connected it to an infection outbreak affecting 60 people in eight states.

That investigation also detected b. cepacia in the water system used to manufacture the product.

Philip Holste, assistant town administrator in Davie, said by phone on Monday that the water system mentioned in the report referred to the company’s internal water system, and not the town’s water supply.

Holste said he had no other information about the company’s June departure from its laboratory in an industrial park at 4131 SW 47th Ave.