FDA Warns Against Use of Any Liquid Product From PharmaTech

FDA Warns Against Use of Any Liquid Product From PharmaTech

http://www.medscape.com/viewarticle/883981

Clinicians and patients should not use any liquid product manufactured by Pharma Tech LLC and distributed by Rugby Laboratories because of Burkholderia cepacia contamination and the potential for severe patient infection, the US Food and Drug Administration (FDA) advised today in a safety communication. 

Dicto Liquid. Photo courtesy of the FDA

On August 3, Rugby Laboratories, of Livonia, Michigan, announced a voluntary recall of two oral liquid docusate products — Diocto Liquid and Diocto Syrup — manufactured by PharmaTech, of Davie, Florida.

“Additional liquid drug products manufactured by PharmaTech might also be affected. Such products might have been labeled and distributed by Rugby and other companies. Any company that purchased liquid products manufactured by PharmaTech should immediately quarantine material under their control and contact the local FDA pharmaceutical recall coordinator,” the FDA advised.

 

The agency acknowledges that it might be tough to determine the manufacturer because these liquid products are not labeled with a PharmaTech label. Healthcare facilities and pharmacies that think they might have liquid PharmaTech drug products, especially oral liquid docusate drug products, should check with their supplier to determine who manufactured the product, the FDA said. 

According to the FDA, laboratory testing of PharmaTech’s oral liquid docusate, conducted by the Centers for Disease Control and Prevention (CDC), found a strain of B cepacia, which has been linked to recent infections in patients.

In 2016, the CDC and the FDA advised against using any liquid docusate drug products.

An investigation into a 2016 multistate outbreak identified B cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, which was linked to patient infections that required intensive medical treatment. The 2016 investigation also detected B cepacia in the water system used to manufacture the product, the FDA said.

This year, the agency said it has received reports of “several adverse events” related to oral liquid docusate sodium products. 

Healthcare professionals are encouraged to report problems related to these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program

One Response

  1. Dear Pharmacist Steve,
    Since my diagnosis of herniated lumbar discs, along with some spondylitis, arthritis and stenosis in my lumbar spine, I have been using physical therapy, TENS (I bought my own when my Medicare denied it) – and percocet 5/325 which really helps.
    The relief from the TENS helps but is short-lived. The two epidural steroidal injections have as yet not helped much.
    I tried to fill my prescription for a 5 day supply yesterday and was told it was blocked. It was the fifth day. I have been prescribed this medication many times, in 5 day supplys. It is 25 pills, taken every 4 to 6 hrs as needed.
    The pharmacist said she’d try and run it through tomorrow to see it would be OK’s to fill. I am hoping it gets filled as I have run out (on the fifth day as prescribed). Otherwise the can get excruciating.
    My question is – why has it been blocked? I’m under the maximum monthly limit- I checked!
    Any advise would be most helpful.
    Thanks,
    G.J.

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