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Regulatory Focus™ > News Articles > FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs

FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs

Posted 09 August 2017 | By Michael Mezher 

FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs

The US Food and Drug Administration (FDA) on Wednesday warned patients and health care professionals not to use liquid drugs made by Florida-based contract manufacturing organization (CMO) PharmaTech LLC due to possible bacterial contamination.

Last week, Rugby Laboratories issued a voluntary nationwide recall of all lots of two liquid docusate sodium laxatives, Diocto Liquid and Diocto Syrup, made by PharmaTech due to possible Burkholderia cepacia contamination.

While B. cepacia poses little risk to healthy people, the US Centers for Disease Control and Prevention (CDC) warns that patients with weakened immune systems or chronic lung diseases such as cystic fibrosis are at a much greater risk for infection.

Additionally, CDC says that B. cepacia is resistant to many common antibiotics, making infection difficult to treat.

In August 2016, PharmaTech recalled all liquid products it made over a 10 month period from October 2015 to July 2016 following a multi-state B. cepacia outbreak that was ultimately traced to 10 lots of docusate sodium made by PharmaTech. The recall impacted products labeled and distributed by Rugby and five other companies: Major, Bayshore, Metron, Centurion and Vitrus.

While FDA's latest advisory extends to all liquid products made by PharmaTech, the agency has not provided a current list of all the affected products or distributors.

Instead, the agency says pharmacies and health care professionals should to check with their suppliers to figure out whether suspected products were manufactured by PharmaTech.

"It might be difficult to determine the manufacturer because these liquid products are not labeled with a PharmaTech label," FDA writes. Current federal regulations require that a drug be labeled with the name and place of business of the manufacturer, packager or distributor.

Erin Fox, director of drug information the University of Utah Health Care told Focus that this lack of information makes it difficult to respond to such advisories.

"I think a key concern is that FDA knows there is a problem with PharmaTech—but they don't quite have the list of all the companies that repackage PharmaTech products," Fox said.

Because of this, Fox said it will be difficult for patients and pharmacists to tell whether a product was manufactured by PharmaTech.

"This is frustrating because there is virtually no way to purchase a medication based on quality. You can watch for [Form 483s] or warning letters and try to avoid those companies, but at the end of the day if you don't know the company that actually made the product, you can't really know what you are buying," she said.

As a precaution, Fox said her university's pharmacy pulled its stock of Rugby products, but would have to wait for confirmation from Rugby before they could be certain whether the products were made by PharmaTech.



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