【召回】Baxter氯化钠注射液多批有昆虫

毒手药王邓智先

2016-01-06召回的是250ml的0.9%的氯化钠注射液，因为有位患者抱怨在输液中发现了昆虫。
今年该公司进行多次召回
十月份该公司还召回140,000袋氯化钠注射液，因为担心含有霉菌
七月召回了两批产品，因为经证明微粒为昆虫。
四月召回了600,000袋产品

毒手药王邓智先

One recall of three lots in April last yearalone accounted for 600,000 bags of product. It recalled two lots in Julybecause of particulate that turned out to be insects.
More woes for the U.S. supply of salinesolution as Baxter International ($BAX) announced another voluntary recall ofits products. This time, two lots of intravenous solutions have been recalleddue to the presence of particulate matter after a customer complained of aninsect found in the product, the FDA said.
The lots being recalled are for 0.9% sodiumchloride injection, USP, 250-milliliter Viaflex plastic container used for IVsand 70% dextrose injection (2,000 milliliter) USP. Both products are typicallyused for caloric intake and hydration of patients. The lots were distributed inthe U.S. between June 6 and Dec. 16 last year.
Using the product could result in bloodvessel blockage, which can cause a stroke, heart attack or damage to othermajor organs as well as possible allergic reactions.
The recall isn't expected to affect currentsupply and product remains available for current customers, the agency said.
In October, the Deerfield, IL, companyrecalled nearly 140,000 bags of sodium chloride due to the possibility some ofthe saline solution bags contained mold. That voluntary recall was initiatedafter Baxter received a complaint of mold on the interior surface of anoverpouch, which was made at its plant in Jayuya, Puerto Rico. That facilitygot an FDA warning letter two years ago for a number of problems, including 20nonconformance reports on liquid products containing everything from skin tohuman hair to rayon.
For about three years now, the U.S. hasbeen battling shortages of saline, one of the most frequently used products inhospitals. To help replenish the nation's supply chain, it has allowed theimport of product from some plants in Europe that were not previously approvedfor U.S. distribution. A Baxter plant in Spain was approved last year, and theagency has also granted temporary permission to a Fresenius Kabi plant inNorway and a B. Braun plant in Germany.
However, repeated recalls by Baxter andHospira have kept the U.S. supply chain from getting fully replenished. Baxterhas had a number of recalls of saline this year amounting to hundreds ofthousands of bags. One recall of three lots in April last year alone accountedfor 600,000 bags of product. It recalled two lots in July because ofparticulate that turned out to be insects.
http://www.fiercepharmamanufactu ... as-found/2016-01-06

hope_y8crE

这么夸张啊

lhqboy

虫鼠害控制完全失败！

赶紧整改：照片虫鼠害专业研究员+挡鼠板+灭蝇灯+风幕机+防虫膜+。。。。。
重要的是管理体系呀

syhorchid

有这种事？

小小男人

貌似进入昆虫星球大战。

八戒

注射剂能搞出这种事情来，看来质量管理体系还不如国内的企业啊

从头再_I1qoO

输液在A级环境下灌装，外企有可能会使用隔离系统，过氧化氢灭菌，药液终端除菌过滤，最大的可能会出在瓶子环节，瓶子在C级下吹瓶，瓶胚被污染，瓶子经过气吹，水洗工位，看样子昆虫附着力很强。国内三线输液企业也不可能出现这样的问题

charls

太震惊了，赶紧关门整改，谁还敢用

XQW

有点不可思议

尼采

这还不被撤销证书

幻影

这个体系多个环节出现问题？防虫，过程检查，产品检查，没有一环发挥作用？

xupeiyun7963

这家企业真牛！
另外，经过这么多批次的召回，药品监管部门何在？！应当引起重视，出杀手锏啦！

美好药店

有根据吗？消息属实吗？

美好药店

是中国国内工厂吗？

kwy

Baxter 是中国的吧，太low了，拉低形象。

porsche1921

百特也这样？

nancy500

百特的质量系统还真是堪忧啊

祁莉萍_P4B80

是不是考虑停产整顿先

道我_Ykdg8

毒手药王 发表于 2016-1-8 19:58
One recall of three lots in April last yearalone accounted for 600,000 bags of product. It recalled  ...

500强也有失足啊