ST LOUIS (MD Consult) - On May 28, 2010, the US Food and Drug Administration (FDA) announced that Blacksmith Brands is conducting a voluntary recall of all lots of 4 children's products in the PediaCare line. The items involved in the recall are the following:
- PediaCare Multi-Symptom Cold 4 oz, UPC # 3 0045-0556-05 9;
- PediaCare Long Acting Cough 4 oz, UPC# 3 0045-0465-04 7;
- PediaCare Decongestant 4 oz, UPC# 3 0045-0554-04 8; and
- PediaCare Allergy and Cold 4 oz, UPC# 3 0045-0552-04 4.
Blacksmith Brands initiated the recall as a precautionary step because the products were made at the McNeil Consumer Healthcare plant in Fort Washington, Pa. The plant was temporarily shut down after a recent inspection at that facility found serious problems in meeting the FDA's current good manufacturing practice requirements. The recall was not initiated as a result of any consumer reports of adverse events, and no consumer complaints have been received about the safety or purity of the products.
Tiny particles have been found in other non-PediaCare products that were manufactured at the McNeil plant.
Blacksmith Brands is advising consumers who have purchased these recalled products to discontinue use. The company also is asking retail and wholesale customers to withdraw the 4 products from their shelves and warehouses.
Items not involved in this recall are PediaCare Allergy 4 oz, PediaCare Gentle Vapors plug-in units, and PediaCare Gentle Vapors refills, all of which are produced in other facilities.
圣路易斯(MD Consult)——2010年5月28日，美国食品药品管理局(FDA)宣布，Blacksmith Brands目前正在自愿召回PediaCare产品线中4种儿科用药所有批次的产品。这次被召回的产品包括：
- PediaCare Multi-Symptom Cold 4盎司装，UPC # 3 0045-0556-05 9；
- PediaCare Long Acting Cough 4盎司装，UPC# 3 0045-0465-04 7；
- PediaCare Decongestant 4盎司装，UPC# 3 0045-0554-04 8；以及
- PediaCare Allergy and Cold 4盎司装，UPC# 3 0045-0552-04 4。
由于上述产品是在麦克尼尔消费者医疗保健部位于美国宾夕法尼亚州华盛顿堡的工厂生产的，因此Blacksmith Brands启动了这次预防性召回行动。近期在对这家工厂展开调查后，发现其在遵守FDA的现行药品生产质量管理规范的要求方面存在严重问题，因此这家工厂被迫暂时关闭。这次召回并不是因消费者不良事件报告而引起的，目前尚未收到关于这些产品安全性或纯度的任何消费者投诉。
在麦克尼尔这家工厂生产的其他非PediaCare系列的产品中发现了一些微小颗粒。
Blacksmith Brands建议已经购买了上述召回产品的消费者暂停使用这些产品。该公司还要求零售商和批发商将这4种产品撤柜或撤库。
不在此次召回之列的产品包括：PediaCare Allergy 4盎司装，PediaCare Gentle Vapors plug-in units和PediaCare Gentle Vapors refills，所有这些产品都是在其他工厂生产的。
