Recalls / Class II
Class IID-0897-2021
Product
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
- Affected lot / code info
- Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-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
- 589 bags
- 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-0897-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.