ceFAZolin Injectable Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services LLC is recalling ceFAZolin 2 G/20 mL sterile syringes for injection due to lack of sterility assurance. Approximately 2,614 syringes distributed in NH, MA, and MN are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug product with a fundamental sterility failure. Lack of sterility assurance in an injectable medication poses significant infection risk and meets the Severe classification threshold for injectable pharmaceutical recalls where patient harm exposure is substantial.
Plain-English summary
IntegraDose Compounding Services LLC is recalling ceFAZolin, 2 G/20 mL in Sterile Water, supplied in 20 mL Sterile Syringes for Injection (NDC 71139-7087-1) due to lack of sterility assurance.
The recall affects approximately 2,614 syringes. Multiple lots are included in this recall with expiration dates ranging from September 17, 2021 to September 26, 2021. The affected product was distributed to healthcare facilities in New Hampshire, Massachusetts, and Minnesota.
Consumers and healthcare providers who have received this product should not use it. Any remaining product should be quarantined and returned to the manufacturer or disposed of according to institutional waste-management protocols.
The recalled product
- 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
- Manufacturer
- IntegraDose Compounding Services LLC
- Category
- Drug — Injectable / Compounded
- Affected units
- 2,614
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 (17)
- 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
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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