For Immediate Release
August 8, 2016
Angelina Reyburn, Recall Coordinator
PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.
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.
Bayshore: Aller-chlor Antihistamine 120 mL, NDC 0536-1025-47, Lot# 23261501, Exp. Date 10/2017For a full list of recalled products see the company press release.
As part of its commitment to patient safety, PharmaTech, LLC is working to notify customers who may be in possession of the affected products. PharmaTech-LLC has not received any complaints to date of contamination in the products and the associated lot numbers. Please see the attachment for affected products and lot numbers.
PharmaTech, LLC is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.
Consumers with questions regarding this recall should contact Angelina Reyburn, Recall Coordinator at (754) 701-8320, Monday through Friday 8a – 5p EST. Consumers can contact their physician or healthcare provider if they have additional questions about these products.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
Regular Mail or Fax: Download form: www.fda.gov/medwatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-address form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the full knowledge of the U.S Food and Drug Administration.