Rappel de supplément liquide dans tout le pays par des marques multiples dues à une Contamination

Un rappel volontaire à l’échelle nationale de tous les liquides produits fabriqués par Pharmatech LLC et distribué par la marque Leader, Major Pharmaceuticals, et les laboratoires de Rugby en raison de la Contamination Possible du produit.

Un rappel volontaire à l’échelle nationale de tous les liquides produits fabriqués par Pharmatech LLC et distribué par la marque Leader, Major Pharmaceuticals, et les laboratoires de Rugby en raison de la Contamination Possible du produit

Par mesure de précaution, 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. Consommateurs, 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: 096295128611ALL LOTS
Liquid Vitamin D Supplement for Breastfed Infants 400 UI 50 mL,UPC: 096295128628ALL LOTS
MAJOR PHARMACEUTICALS
Certa-Vite Liquid236ML00904-5023-09ALL LOTS
Gouttes de poly-Vita50ML00904-5099-50ALL LOTS
Poly-Vita Drops W/Iron50ML00904-5100-50;ALL LOTS
Ferrous Drops Iron Supp50ML00904-6060-50ALL LOTS
Gouttes de D-Vita50ML00904-6273-50ALL LOTS
Tri-Vita Drops50ML00904-6274-50ALL LOTS
Sirop de Senna237ML00904-6289-09ALL 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 sirop16OZ00536-2770-85ALL LOTS
Cerovite liquide236ML00536-2790-59ALL 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

 

Images de produits

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. Les consommateurs peuvent communiquer avec leur médecin ou un professionnel de la santé s’ils ont des questions supplémentaires sur ce produit.

Effets indésirables ou des problèmes de qualité rencontrés avec l’utilisation de ces produits peuvent être signalés à la Programme de déclaration des événements indésirables MedWatch de la FDA.

Ce rappel est mené avec la pleine connaissance des États-Unis. Food and Drug Administration.

Source: FDA

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