June 15, 2017
SCA Pharmaceuticals is recalling cefazolin sodium added to 100 mL 0.9% sodium chloride injectable single-dose container bags because of concerns over sterility, according to the June 7, 2017, US Food and Drug Administration (FDA) Enforcement Report.
The recall stems from product bags that leaked at the seam. The affected include:
- 240 bags that are 2g, for a total approximate volume of 100 mL, from lot 20170510@12 (Exp. 6/24/17)
- 70 bags that are 3g, for a total approximate volume of 115 mL, from 20170508@15 (Exp. 6/22/17).
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SCA Pharmaceuticals voluntarily initiated the cefazolin sodium recall May 18, 2017. On May 31, the FDA designated it Class II, indicating the affected drugs may cause reversible adverse health consequences that are not likely to be serious.
Cefazolin injection is a prescription-only cephalosporin antibiotic used to prevent or treat infections.