The U.S. Food and Drug Administration have released a notification about another product recall due to microbiological contamination.
The product is manufactured by Hospira: Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09.
The recall has come about because of a customer report where a leak was identified in the primary container between the cobra cap and fill-tube seal and a spore-like structured particulate, consistent with mold, was noted in the solution.
The risk is that if contaminated solution is used on a patient, critical patient harm may result. Injections of mold could potentially lead to septicemia (blood stream infections), which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening.
Further details are provided by the FDA MedWatch.