Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product ContaminationIncluding drug products: Aller-chlor Antihistamine Including dietary supplement products: Calcionate Syrup AUDIENCE: Pediatrics, Pharmacy, Family Practice, Consumer ISSUE: PharmaTech, LLC is voluntarily recalling all liquid products due to a potential risk of product contamination with Burkholderia cepacia. See the press release for a complete listing of affected products. 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. BACKGROUND: This recall affects all liquid products from October 20, 2015 through July 15, 2016. RECOMMENDATION: 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. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the press release, at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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