Medicine recalls
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| The United States: Rugby Laboratories issues voluntary nationwide recall of Diocto Liquid and Diocto Syrup manufactured by PharmaTech, LLC due to possible product contamination |
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The US Food and Drug Administration (FDA) announces that Rugby Laboratories of Livonia, MI is voluntarily recalling all lots within the expiry of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC of Davie, FL due to a risk of product contamination with Burkholderia cepacia.
Diocto Liquid (50mg/5mL) and Diocto Syrup (60mg/15mL) are used as stool softeners and are packaged in one pint (473mL) bottles. FDA has informed Rugby that it received several adverse event reports of B. cepacia infections in patients which may be linked to Diocto Liquid or Diocto Syrup manufactured by PharmaTech LLC. If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm569967.htm
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by PharmaTech, LLC.
Ends/Friday, Aug 4, 2017
Issued at HKT 16:00
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