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Regulatory Focus™ > News Articles > Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak

Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak

Posted 10 August 2016 | By Michael Mezher 

Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak

Contract manufacturing organization PharmaTech on Monday announced a voluntary recall of all of its liquid drug formulations made at its Davie, Florida facility over a 10-month period after being linked to a multi-state Burkholderia cepacia outbreak.

The recall is an expansion of an earlier recall dated 15 July 2016, in which PharmaTech said it was recalling all lots of Diocto Liquid (docusate sodium), a stool softener, distributed by Rugby Laboratories after the company received reports that the drug was contaminated with B. cepacia.

So far, the US Centers for Disease Control and Prevention (CDC) says it has confirmed 60 cases of B. cepacia infection in eight states. While PharmaTech is the only company linked to the outbreak, CDC and the US Food and Drug Administration (FDA) say that doctors and patients should avoid using any brand of liquid docusate sodium until the outbreak is resolved.

According to the US Centers for Disease Control and Prevention (CDC), "B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections."

 Additionally, CDC says the bacteria is known to be resistant to many common antibiotics, making infection more difficult to treat.

Now, as a precautionary measure, PharmaTech says it is expanding the recall to include all liquid drugs and dietary supplements produced at its Davie, FL facility between 20 October 2015 and 15 July 2016 distributed by Rugby Laboratories, Major, Bayshore, Centurion, Vitrus and Metron.

The recalled products include multiple lots of docusate sodium laxatives, cough syrup, antihistamines and sodium citrate-citric acid, which is used to treat reduce urine acidity for patients with gout and kidney stones. However, PharmaTech says it has not received any reports indicating contamination in the additional products listed in the expanded recall.

While the source of the contamination so far remains unclear, FDA investigators cleared PharmaTech's Davie, FL facility after a 10-day inspection that took place in February and March. "The site was found to be compliant with the principles and guidelines of Current Good Manufacturing Practices (cGMP), and no Form 483 observations were issued," the company said in a press release following the inspection.


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