PharmaTech expands recall of drugs made at Florida plant linked to B. cepacia outbreak

By Gareth Macdonald

- Last updated on GMT

PharmaTech recalls more durgs over B. cepacia risk
PharmaTech recalls more durgs over B. cepacia risk

Related tags Food and drug administration Pharmaceutical drug

PharmaTech LLC has recalled more drugs made at the Florida plant that was linked an outbreak of B. cepacia last month.

On Monday​ the contract manufacturing organisation (CMO) announced it was recalling all liquid products made at the Davie, Florida manufacturing site since October last year.

The firm said there is a risk the medicines could be contaminated with Burkholderia cepacia​.

The recalled products are sold by Rugby Laboratories, Major Pharmaceuticals, Bayshore Pharmaceuticals, Centurion Labs and Vitrus Pharmaceuticals.

Last Month​ PharmaTech withdrew a constipation medication - Diocto Liquid (NDC 0536-0590-85) – made at the facility after it was linked to 46​ cases of B. cepacia ​infection the US Centers for Disease Control and Prevention (CDC).

In March the Davie facility passed an FDA inspection and was found to be "compliant with the principles and guidelines of Current Good Manufacturing Practices (cGMP), and no Form 483 observations were issued​."

B. cepacia ​outbreak

According to the latest CDC update products made by PharmaTech have been linked to 58 cases B. cepia​ infection in 8 US states.

Related topics Markets & Regulations QA/QC

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