The Food & Drug Administration (FDA) has announced
recall of all liquid products manufactured by PharmaTech, and
three companies: Leader Brand, Major Pharmaceuticals, and Rugby
Laboratories, due to possible Burkholderia
announced the recall on Thursday saying the products, including various
and dietary supplements intended for use in infants and children, were
the recall announcement for
a complete list
of recalled products with photos.
says patients, pharmacies, and healthcare facilities that have the
product on hand should stop using and dispensing them immediately.
with questions regarding this recall can contact the companies at the
Customer Support: at 1-800-200-6313, option #1, Monday through Thursday
– 7p.m. and Friday 8 a.m. – 5 p.m. EST
Laboratories/Major Pharmaceuticals Customer Support: 1-800-645-2158,
through Friday 8 a.m. – 8 p.m. EST
says it "encourages health care professionals and patients to report
adverse events or quality problems experienced with the use of these
products" to FDA’s MedWatch Adverse Event
and submit the report online atwww.fda.gov/medwatch/report.htm;
and complete the form,
then submit it via fax at
separate announcement, the distribution companies said the recall was a
precautionary measure and that the products subject to this recall were
distributed nationwide to wholesale and retail
including hospitals and pharmacies.
statement said, "Through recent communication with FDA, the
firm Rugby Laboratories learned of a potential issue with a product
manufactured by PharmaTech LLC.
informed Rugby Laboratories that it received several adverse event
of B. cepacia infections in patients,
which may be linked to
PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid (docusate
response, Rugby Laboratories issued a voluntary recall on August 3,
2017, of the
PharmaTech LLC manufactured Diocto Syrup and Diocto Liquid. As a
measure based on additional information received from the FDA, the
distribution firms are recalling all lots within expiry of all liquid
manufactured by PharmaTech LLC."
distribution firms are notifying their distributors and customers by
letter and are arranging for return of all recalled products.
pharmacies, and healthcare facilities that have product being recalled
using and dispensing the product immediately.
can contact their physician or healthcare provider if they have
questions about this product.