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