Ceftriaxone injectable antibiotic recalled for lack of sterility assurance
Sentara Infusion Services recalled 72 bags of ceftriaxone injectable antibiotic due to lack of sterility assurance. The affected product was distributed nationwide with a beyond-use date of December 24–31, 2022.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving injectable medication with documented lack of sterility assurance is a risk-of-harm product. No illnesses or injuries have been reported in the source material.
Plain-English summary
Sentara Infusion Services has recalled ceftriaxone injectable antibiotic (available as 2 grams in 100 mL normal saline or 4 grams in 200 mL normal saline) due to lack of sterility assurance. A total of 72 bags were affected by this recall.
The recalled product was dispensed to patients nationwide. The affected units had a beyond-use date of December 24–31, 2022. Injectable medications must maintain strict sterility standards to prevent infection when administered directly into the bloodstream.
Patients who received this medication or healthcare providers who administered it during the affected period should consult their healthcare provider if they have concerns about potential exposure. The product should not be used if any units remain available.
The recalled product
- Product
- CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Antibiotic Injectable
- Affected units
- 72
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 (2)
- Beyond Use Date: December 24-31
- 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 53 recalled by Sentara Infusion Services 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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