Daptomycin Injectable Antibiotic Recalled Due to Sterility Assurance Failure
Sentara Infusion Services is recalling daptomycin injectable antibiotic bags due to lack of sterility assurance. The 17 affected bags were dispensed nationwide and pose a potential infection risk.
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: This is an FDA Class II recall of an injectable antibiotic with a critical safety failure (lack of sterility assurance). Although no illnesses have been reported, sterility failure in injectable drugs poses a significant risk of infection and meets the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling daptomycin injectable antibiotic (400mg in normal saline 20ml and 550mg in normal saline 27.5ml) due to lack of sterility assurance. The recall affects 17 bags of the medication.
The affected bags failed to meet sterility assurance standards, which ensure injectable medications are free from bacterial contamination. This failure creates a risk of infection for patients who receive the medication.
The affected daptomycin bags have a beyond-use date of December 24-31, 2022, and were dispensed to patients nationwide through Sentara Home Infusion Pharmacy Services. Patients and healthcare providers who have this medication should be aware of this recall.
If you or your patient received daptomycin from Sentara Home Infusion Pharmacy Services, contact your healthcare provider immediately. Do not use the medication. Your provider can advise you on alternative antibiotic treatments.
The recalled product
- Product
- DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Affected units
- 17
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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