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.
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. No batches of distributed product have been identified as actually containing microorganisms. To date, Hospira has not received reports of any adverse events associated
COMMENT:
Routine simulation of the manufacturing process (media fills) are routinely performed at six month increments. One of the main purposes for performance at these intervals is to assure that product manufactured during the interval from the previous media fills has not had its manufacturing process compromised. As noted above, the possibility of a breach in sterility assurance, while remote, cannot be eliminated. A very good reference on this topic is the FDA Aseptic Processing Guidance (September 2004) (Click Here).
Click here to obtain the complete recall letter (Click Here) as well as view my upcoming webinars and seminars (Click Here)
Leave a Reply