IntegraDose Compounding Recalls 11 Cefazolin Lots

IntegraDose Compounding Services is recalling nine lots of antibiotic cefazolin 2g in 20 mL syringes for injection and two lots of cefazolin 3g in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance. The sterility issue was traced to a newly installed biologic safety cabinet placed into service without completing a dynamic smoke study testing, according to a recall notice.

“Intravenous administration of a non-sterile drug could result in serious infections ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection which may be life-threatening,” the notice says. No batches of product have been identified as containing microorganisms, it adds.

IntegraDose Compounding Services recalls nine lots of antibiotic cefazolin 2g in 20 mL syringes for injection and two lots of cefazolin 3g in 100 mL 0.9% sodium chloride bag for injection due to sterility assurance concerns.