PharMEDium Services Recalls 2 Drugs

FDA says that PharMEDium Services has issued a nationwide recall of specific lots of potassium phosphate and succinylcholine chloride due to a lack of sterility assurance. An agency publication of a company announcement says that PharMEDium Services’ recall is due to Hospira’s 6/15 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process, leading to a lack of sterility assurance. The products being recalled by PharMEDium were compounded using certain Hospira products, it says.

According to Hospira, if an affected 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 mycosis or systemic bacterial sepsis.

PharMEDium says that to date it has not received any reports of product complaints or adverse effects related to the products.