Recalls / Class II
Class IID-0896-2021
Product
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
- Affected lot / code info
- Lot, expiry: Lot 20210803CEF-1, exp 09/17/2021; Lot 20210805CEF-3, 09/19/2021; Lots 20210806CEF-1, 20210806CEF-2, exp 09/20/2021; Lots 20210809CEF-1, 20210809CEF-2, exp 09/23/2021; Lot 20210810CEF-1, exp 09/24/2021; Lot 20210811CEF-1, exp 09/25/2021; Lot 20210812CEF-1, exp 09/26/2021
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- IntegraDose Compounding Services LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 719 Kasota Ave Se, N/A, Minneapolis, Minnesota 55414-2842
Distribution
- Quantity
- 2,614 syringes
- Distribution pattern
- NH, MA, MN
Timeline
- Recall initiated
- 2021-09-17
- FDA classified
- 2021-09-30
- Posted by FDA
- 2021-10-06
- Terminated
- 2022-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0896-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.