IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.
|
Product
|
NDC
|
Lot
|
Exp
|
|
Cefazolin 2 gram in 20 mL syringe for injection
|
71139-7087-1
|
20210803CEF-1
|
09/17/2021
|
|
71139-7087-1
|
20210805CEF-3
|
09/19/2021
|
|
71139-7087-1
|
20210806CEF-1
|
09/20/2021
|
|
71139-7087-1
|
20210806CEF-2
|
09/20/2021
|
|
71139-7087-1
|
20210809CEF-1
|
09/23/2021
|
|
71139-7087-1
|
20210809CEF-2
|
09/23/2021
|
|
71139-7087-1
|
20210810CEF-1
|
09/24/2021
|
|
71139-7087-1
|
20210811CEF-1
|
09/25/2021
|
|
71139-7087-1
|
20210812CEF-1
|
09/26/2021
|
|
Cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection
|
71139-7053-1
|
20210722CEF-2
|
09/20/2021
|
|
71139-7053-1
|
20210728CEF-1
|
09/26/2021
|
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.
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