近日，FDA官网发布了辉瑞Hospira, Inc正在召回其无菌注射剂产品，原因为其培养基模拟灌装失败，怀疑产品受微生物污染。
摘译如下：
Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
辉瑞Hospira对医院和零售主动召回42批8.4%碳酸氢钠注射液，50ml瓶，5批NeutTM（碳酸氢钠添加剂溶液），5ml瓶，5批QUELICINTM（琥珀酰氯化胆碱注射液）20mg/10ml瓶和7批磷酸氢钾注射液，45mM瓶，因为在一个常规的生产工艺模拟分装中发现有微生物生长，表示产品也有可能被引入了微生物。
In the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated.
一旦这些药品被用在病人身上，很有可能病人将发生不良反应，包括发烧、寒颤、不适，甚至严重不良反应，包括系统侵袭性真菌病或系统性细菌败血症。已分销的产品无法排除无菌保证存在缺陷的可能性。