Bundesweite flüssige Ergänzung Rückruf von mehreren Marken wegen der Verschmutzung

Freiwillige bundesweit erinnern alle flüssigen Produkte hergestellt von Pharmatech LLC und verteilt durch führende Marke, Major Pharma, und Rugby Labors durch mögliche Produktkontaminationen.

Freiwillige bundesweit erinnern alle flüssigen Produkte hergestellt von Pharmatech LLC und verteilt durch führende Marke, Major Pharma, und Rugby Labors durch mögliche Produktkontaminationen

Als Vorsichtsmaßnahme, the distribution firms Leader Brand, Major Pharma, 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).

Als Reaktion, 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. Verbraucher, Apotheken, 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: 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 Tropfen50ML00904-5099-50ALL LOTS
Poly-Vita Drops W/Iron50ML00904-5100-50;ALL LOTS
Ferrous Drops Iron Supp50ML00904-6060-50ALL LOTS
D-Vita-Tropfen50ML00904-6273-50ALL LOTS
Tri-Vita Tropfen50ML00904-6274-50ALL LOTS
Senna Sirup237ML00904-6289-09ALL 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 Sirup16OZ00536-2770-85ALL LOTS
Cerovite Flüssigkeit236ML00536-2790-59ALL 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

 

Produktbilder

Consumers with questions regarding this recall should contact Rugby Laboratories/Major Pharmaceuticals Customer Support at 1-800-645-2158, available Monday through Friday 8 Uhr. – 8 p.m. EST or Leader Customer Support at 1-800-200-6313 option #1 Monday through Thursday 8 Uhr. – 7p.m. and Friday 8 Uhr. – 5 p.m EST. Verbraucher können ihren Arzt oder Arzt zu kontaktieren, wenn sie weitere Fragen zu diesem Produkt haben.

Nebenwirkungen oder Qualitätsprobleme mit der Verwendung dieser Produkte gemeldet werden können die FDA MedWatch nachteilige Event Reporting Programm.

Dieser Rückruf wird mit dem vollen Wissen von den USA durchgeführt. Food and Drug Administration.

Quelle: FDA

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