全国范围内的液体补充品召回由污染引起的多个品牌

自愿全国范围内召回所有液体产品制造的药明康德 LLC 和分布式的领导品牌, 主要药品, 和可能的产品污染引起的橄榄球实验室.

自愿全国范围内召回所有液体产品制造的药明康德 LLC 和分布式的领导品牌, 主要药品, 和可能的产品污染引起的橄榄球实验室

作为预防措施, the distribution firms Leader Brand, 主要药品, 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. 消费者, 药房, 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 毫升,UPC: 096295128611ALL LOTS
Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 毫升,UPC: 096295128628ALL LOTS
MAJOR PHARMACEUTICALS
Certa-Vite Liquid236ML00904-5023-09ALL LOTS
聚-维塔滴50ML00904-5099-50ALL LOTS
Poly-Vita Drops W/Iron50ML00904-5100-50;ALL LOTS
Ferrous Drops Iron Supp50ML00904-6060-50ALL LOTS
D-维塔滴50ML00904-6273-50ALL LOTS
三 Vita 滴50ML00904-6274-50ALL LOTS
塞纳糖浆237ML00904-6289-09ALL 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 糖浆16盎司00536-2770-85ALL LOTS
Cerovite 液体236ML00536-2790-59ALL 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

 

产品图片

Consumers with questions regarding this recall should contact Rugby Laboratories/Major Pharmaceuticals Customer Support at 1-800-645-2158, available Monday through Friday 8 上午. – 8 下午. EST or Leader Customer Support at 1-800-200-6313 option #1 Monday through Thursday 8 上午. – 7p.m. and Friday 8 上午. – 5 p.m EST. 消费者,如果他们有这种产品的附加疑问的话,可以联系他们的医生或医疗服务提供者.

不良反应或熟悉使用这些产品的质量问题,可报请 FDA 的 MedWatch 不良事件报告程序.

这次召回正在进行与美国的全面知识. 食品和药物管理局.

来源: FDA

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