FDA recalls Diocto Liquid nationwide
LOUISVILLE, KY (WAVE) - The FDA has recalled Diocto Liquid nationwide because of infections that could life-threatening.
Diocto Liquid is made at PharmaTech LLC in Davie, FL, a Rugby branded produced manufactured and may have been contaminated with Burkholderia cepacia.
The use of Diocto Liquid contaminated with B. cepacia could cause life-threatening infections in patients with compromised immune systems and with chronic lung conditions like cystic fibrosis.
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Rugby Laboratories is working with PharmaTech LLC to notify those who may be in possession of the contaminated product NDC 0536-0590-85; 50 mg/5 mL for all lots within the expiration period. They will be notified by letter and will arrange for the returned of all recalled products. If you have a recalled product, you should stop using and dispense of the product immediately.
Those will questions can call Rugby's customer support department at 1-800-645-2158 Monday through Friday from 8 a.m. to 9 p.m. EST.
Quality problems or adverse reactions that have been caused from Diocto Liquid should be reported to the FDA's MedWatch Adverse Event Reporting program by submitting a report here or downloading the form here and submitting it to the address on the form or faxing it to 1-800-FDA-0178.
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