ceFAZolin Injectable Drug Bags Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services is recalling ceFAZolin 3 G in 0.9% Sodium Chloride injectable bags due to lack of sterility assurance. The recall affects 589 bags distributed to New Hampshire, Massachusetts, and Minnesota.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II drug recall involving a sterile injectable product with compromised sterility assurance. Lack of sterility in injectable medications poses significant risk of serious infection and constitutes a major manufacturing control failure for a health-critical product, meeting the Severe threshold.
Plain-English summary
IntegraDose Compounding Services LLC is recalling ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product due to lack of sterility assurance. The affected product was distributed to hospitals and healthcare facilities in New Hampshire, Massachusetts, and Minnesota.
The two affected lots are: - Lot 20210722CEF-2, expiring 09/20/2021 - Lot 20210728CEF-1, expiring 09/26/2021
A total of 589 bags are subject to this recall. Patients who have received this injectable product should consult with their healthcare provider immediately. Healthcare facilities should quarantine any remaining stock of the recalled lots and not use them for patient care.
The recalled product
- 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
- Manufacturer
- IntegraDose Compounding Services LLC
- Affected units
- 589
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot
- expiry: 20210722CEF-2
- exp 09/20/2021
- 20210728CEF-1
- exp 09/26/2021
Distribution
Part of a larger recall action
This product is one of 2 recalled by IntegraDose Compounding Services LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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