UPDATE [10/12/2016] FDA and CDC find direct link of contaminated water at PharmaTech to the multistate B. cepacia outbreak
An FDA investigation associated with a multistate outbreak has identified the bacteria, Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida. The investigation also detected B. cepacia in the water system used to manufacture the product. These products were manufactured by PharmaTech and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
FDA also inspected other oral liquid docusate sodium manufacturers and collected samples of their products. The bacteria associated with this multistate outbreak has not been found in other oral liquid docusate sodium products FDA tested.
Laboratory evidence from FDA and CDC supports PharmaTech as the source of this outbreak.
In addition, FDA’s current laboratory results do not indicate the active pharmaceutical ingredient used to manufacture oral liquid docusate is a source of the B. cepacia outbreak.
Health care professionals may resume normal use of oral liquid docusate sodium not manufactured by PharmaTech.
FDA reminds manufacturers of the importance of robust manufacturing and testing of liquid products such as docusate sodium to ensure low levels of microorganisms and the absence of those that may cause infection.
FDA will continue to monitor adverse event reports for B. cepacia related to oral liquid docusate sodium. FDA also encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
UPDATE [8/15/2016] FDA issues import alert for all drugs produced by Laxachem Organics in India
The U.S. Food and Drug Administration placed Laxachem Organics Pvt. Ltd., Ahmednagar, Maharashtra, India, on import alert on August 11, 2016, for refusing to allow FDA investigators to inspect its facility. The import alert stops all Laxachem pharmaceutical products from entering the United States legally.
Laxachem will remain on import alert until it has been fully inspected by FDA and found to meet U.S. standards.
Laxachem manufactures active pharmaceutical ingredient (API) for repackagers, labelers, and wholesale drug distributors, some of which sell API to manufacturing facilities in the United States. According to Laxachem’s website, one of the drugs Laxachem manufactures is Docusate Sodium USP.
Companies that received API from Laxachem should not distribute the API or products containing the API to customers.
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), drugs, including APIs, made at a facility that denies, limits, or delays an FDA inspection are considered adulterated. The FD&C Act prohibits distribution of adulterated products.
For more information, see FDA guidance for industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
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UPDATE [8/9/2016] FDA announces voluntary nationwide recall of all liquid products manufactured by PharmaTech and distributed by six companies
FDA is alerting health care professionals and consumers of PharmaTech’s voluntary recall expansion to include all liquid products due to possible Burkholderia cepacia contamination. These products were manufactured in its Davie, Florida, facility, and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
Consumers, pharmacies, and Health care facilities that have product which is being recalled should stop using and dispensing them immediately. Using these products in a patient whose immune system is compromised could result in infections, which may be life-threatening.
To date, FDA has received adverse event reports related to oral liquid docusate sodium and is not aware of any adverse event reports related to the additional recalled products.
FDA and CDC will provide additional information when it is available.
[7/16/16] FDA announces voluntary nationwide recall of oral liquid docusate sodium manufactured by PharmaTech and distributed by Rugby Laboratories
U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.
In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.
Patient safety is our top priority. FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.
FDA and CDC will provide additional information when it is available.
FDA encourages Health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
