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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories: Recall - Possible Product Contamination
AUDIENCE: Pharmacy, Patient
ISSUE: The distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories jointly issued a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.
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.
See the press release for a list of affected products.
BACKGROUND: The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies.
RECOMMENDATION: 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 with questions regarding this recall should contact Rugby Laboratories/Major Pharmaceuticals Customer Support at 1-800-645-2158, available Monday through Friday 8 a.m. – 8 p.m. EST or 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. Consumers can contact their physician or healthcare provider if they have additional questions about this product.
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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the press release, at:
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