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--

FEATURE NEWS

FDA Announces Nationwide Recall
Of Medicinal Liquids
Due to possible Burkholderia cepacia contamination

August 12, 2017




A few of the medicinal liquid products involved in voluntary recall by three distribution firms. CLCK TO ENLARGE
Nationwide Recall Of Medicinal Liquids<br><i> Due to <i>B

(NATIONAL)  --  The Food & Drug Administration (FDA) has announced a voluntary recall of all liquid products manufactured by PharmaTech, and distributed by three companies: Leader Brand, Major Pharmaceuticals, and Rugby Laboratories, due to possible Burkholderia cepacia contamination.

The FDA announced the recall on Thursday saying the products, including various drugs and dietary supplements intended for use in infants and children, were distributed nationwide.

See the recall announcement for a complete list of recalled products with photos.

The FDA says patients, pharmacies, and healthcare facilities that have the recalled product on hand should stop using and dispensing them immediately.

Consumers with questions regarding this recall can contact the companies at the numbers below:

Leader Customer Support: at 1-800-200-6313, option #1, Monday through Thursday 8 a.m. – 7p.m. and Friday 8 a.m. – 5 p.m. EST

Rugby Laboratories/Major Pharmaceuticals Customer Support: 1-800-645-2158, Monday through Friday 8 a.m. – 8 p.m. EST

The FDA 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 Reporting program:

Complete and submit the report online atwww.fda.gov/medwatch/report.htm; or

Download and complete the form, then submit it via fax at 1-800-FDA-0178.

In a 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 facilities, including hospitals and pharmacies.

The statement said, "Through recent communication with FDA, the distribution firm Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech LLC.

The FDA informed Rugby Laboratories that it received several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid (docusate sodium solutions).

In response, Rugby Laboratories issued a voluntary recall on August 3, 2017, of the PharmaTech LLC manufactured Diocto Syrup and Diocto Liquid. As a precautionary measure based on additional information received from the FDA, the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech LLC."

The distribution firms are notifying their distributors and customers by recall letter and are arranging for return of all recalled products.

Consumers, pharmacies, and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.

Consumers can contact their physician or healthcare provider if they have additional questions about this product.

 

 

 

 

 






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