Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories Due to Possible Product Contamination

For Immediate Release

August 10, 2017

Contact

Consumers

Rugby Laboratories/Major Pharmaceuticals Customer Support
1-800-645-2158

Media

Corey Kerr
(614) 757-3383

Announcement

As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing 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.

The distribution firms are committed to patient safety and are partnering with the Food and Drug Administration to notify customers who may be in possession of liquid products manufactured by PharmaTech LLC. Please see the below list of affected products.

The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. 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.

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.

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:

This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration.

LEADER BRAND
Liquid Multivitamin Supplement for Infants and Toddlers 50 mL,UPC: 096295128611ALL LOTS
Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL,UPC: 096295128628ALL LOTS
MAJOR PHARMACEUTICALS
Certa-Vite Liquid236ML00904-5023-09ALL LOTS
Poly-Vita Drops50ML00904-5099-50ALL LOTS
Poly-Vita Drops W/Iron50ML00904-5100-50;ALL LOTS
Ferrous Drops Iron Supp50ML00904-6060-50ALL LOTS
D-Vita Drops50ML00904-6273-50ALL LOTS
Tri-Vita Drops50ML00904-6274-50ALL LOTS
Senna Syrup237ML00904-6289-09ALL LOTS
RUGBY LABORATORIES
C Liquid 500mg118ML00536-0160-97ALL LOTS
Diocto Liquid 50mg/5ml473ML00536-0590-85ALL LOTS
Ferrous Sulfate Elixir473ML00536-0650-85ALL LOTS
Fer Iron Liquid 50ML50ML00536-0710-80ALL LOTS
Senexon Liquid237ML00536-1000-59ALL LOTS
Diocto Syrup 60MG/15ML473ML00536-1001-85ALL LOTS
Aller Chlor Syrup120ML00536-1025-47ALL LOTS
Calcionate Syrup16OZ00536-2770-85ALL LOTS
Cerovite Liquid236ML00536-2790-59ALL LOTS
D3 400iu Liquid50ML00536-8400-80ALL LOTS
Poly-Vitamin Liquid50ML00536-8450-80ALL LOTS
Tri-Vitamin Liquid50ML00536-8501-80ALL LOTS
Poly-Vitamin W/Iron Liquid50ML00536-8530-80ALL LOTS

About Leader™

The Leader™ Brand product line is a broad assortment of quality, healthcare and personal care items available at authorized pharmacies nationwide. A broadly-based distribution network and strong customer loyalty enables Leader™ to offer products with the same active ingredients as nationally-advertised brands, but at significant savings to customers.

About Major Pharmaceuticals

For more than 30 years, Major® has been offering a broad and expanding portfolio of Rx unit dose, bulk and OTC options focused on supporting patient care efforts and providing economic value.

About Rugby® Laboratories

Rugby® Laboratories is a leading provider of high-quality Over the Counter, vitamin, and nutritional supplement products. With more than 40 years of history, Rugby® has been able to build out a comprehensive portfolio of products designed to enhance the quality of life for our consumers while reducing the cost of purchasing their medications.

FDA CORE

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Product Photos

  • Rugby Tri-Vitamin Liquid, 50ML, 00536-8501-80, ALL LOTS 
  • Rugby Senexon Liquid, 237ML, 00536-1000-59, ALL LOTS 
  • Rugby Poly-Vitamin W/Iron Liquid, 50ML, 00536-8530-80, ALL LOTS 
  • Rugby Poly-Vitamin Liquid, 50ML, 00536-8450-80, ALL LOTS 
  • Rugby Ferrous Sulfate Elixir, 473ML, 00536-0650-85, ALL LOTS 
  • Rugby Fer Iron Liquid 50ML, 00536-0710-80, ALL LOTS 
  • Rugby Diocto Liquid 50mg/5ml, 473ML, 00536-0590-85, ALL LOTS 
  • Rugby D3 400iu Liquid, 50ML, 00536-8400-80, ALL LOTS 
  • Rugby Cerovite Liquid, 236ML, 00536-2790-59, ALL LOTS 
  • Rugby Calcionate Syrup, 16OZ, 00536-2770-85, ALL LOTS 
  • Rugby C Liquid 500mg, 118ML, 00536-0160-97, ALL LOTS
  • Rugby Aller Chlor Syrup, 120ML, 00536-1025-47, ALL LOTS 
  • Major Pharmaceuticals Tri-Vita Drops, 50ML, 00904-6274-50, ALL LOTS
  • Major Pharmaceuticals Senna Syrup, 237ML, 00904-6289-09, ALL LOTS 
  • Major Pharmaceuticals Poly-Vita Drops, 50ML, 00904-5099-50, ALL LOTS 
  • Major Pharmaceuticals Poly-Vita Drops W/Iron, 50ML, 00904-5100-50, ALL LOTS 
  • Major Pharmaceuticals Ferrous Drops Iron Supp, 50ML, 00904-6060-50, ALL LOTS 
  • Major Pharmaceuticals D-Vita Drops, 50ML, 00904-6273-50, ALL LOTS 
  • Major Pharmaceuticals Certa-Vite Liquid, 236ML, 00904-5023-09, ALL LOTS 
  • Diocto Syrup 60MG/15ML, 473ML, 00536-1001-85, ALL LOTS 
  • Leader Liquid Multivitamin Supplement for Infants and Toddlers 50 mL, UPC: 096295128611 ALL LOTS 
  • •	Leader Liquid Vitamin D Supplement for Breastfed Infants 400 IU  50 mL, UPC: 096295128628 ALL LOTS 

Page Last Updated: 08/10/2017
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