Nationwide Liquid Supplement Recall by Multiple Brands Due to Contamination

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.

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

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.

Continue Reading Below ↓↓↓

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.

Recalled Products:

LEADER BRAND
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
MAJOR PHARMACEUTICALS
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
RUGBY LABORATORIES
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

 

Product Images

Continue Reading Below ↓↓↓

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.

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

Source: FDA

Comment on this Story