Why it was recalled
Lack of sterility assurance.
Product description
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
Lot numbers, UPCs & expiration codes
Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-1, exp 09/26/2021
Where it was sold
NH, MA, MN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0897-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 589 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- IntegraDose Compounding Services LLC
Original FDA data
Every field from FDA enforcement report D-0897-2021, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 88731
- Address
- 719 Kasota Ave Se
- Code information
- Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-1, exp 09/26/2021
- Postal code
- 55414-2842
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0897-2021
- Classification
- Class II
- Recalling firm
- IntegraDose Compounding Services LLC
- Product quantity
- 589 bags
- Termination date
- Oct 2, 2022
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- NH, MA, MN
- Recall initiation date
- Sep 17, 2021
- Initial firm notification
- Telephone
- Center classification date
- Sep 30, 2021