Daptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Daptomycin pre-filled syringes distributed nationwide due to lack of sterility assurance. Patients using this antibiotic should contact their healthcare provider immediately.
What this means for you
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 with no reported illnesses or injuries. The hazard—lack of sterility assurance in injectable medication—represents a risk-of-harm product without yet-documented harm, meeting the High severity criterion.
Plain-English summary
Sentara Infusion Services is recalling Daptomycin injectable solutions distributed nationwide. The affected products are pre-filled syringes containing 360 mg in 18 mL, 580 mg in 29 mL, or 630 mg in 31.5 mL of Daptomycin in saline, designed for use with home infusion pumps. The recall affects 17 bags with a beyond-use date of December 25-30, 2022.
The recall was issued due to lack of sterility assurance. This means the manufacturer cannot confirm that the product is free from microbial contamination. Daptomycin is an antibiotic used to treat serious bacterial infections, and non-sterile injectable medications pose a risk of infection.
Patients who received this medication should contact their healthcare provider immediately for guidance on whether they were affected and what steps to take. Do not use the product without consulting your medical team. Healthcare providers and patients can contact Sentara Infusion Services for information about their specific doses.
The recalled product
- Product
- DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
- Hazard
- sterility-failure
- infection-risk
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 25-30
- 2022
Distribution
Distributed nationwide across the United States.
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