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Drug Safety Alerts
PharmaTech Liquid Drug Products Consumer-Level Recall
8/15/2017
On August 15, 2017, PharmaTech issued a consumer-level recall of liquid drug products distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories.This recall was issued due to the possible contamination of B. cepacia.
The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. Through recent communication with the United States Food and Drug Administration (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.
A complete list of the affected products is provided here:
CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using products affected by this recall to contact their prescriber.
For more information regarding Rugby Laboratories or Major Pharmaceuticals products, please contact Rugby/Major Customer Support toll-free at 1-800-645-2158, Monday through Friday, 8:00 am to 8:00 pm (ET). For more information regarding product distributed by Leader Brand, please contact Leader Customer Support at 1-800-200-6313 option #1, Monday through Thursday, 8:00 am to 7:00 pm and Friday, 8:00 am. To 5:00 pm (ET). You may also call the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at https://www.fda.gov.