Sentara Recalls Daptomycin Syringes Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of CUBICIN (daptomycin) in NS syringes and homepumps because the sterility of the product cannot be guaranteed.
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: The recall is classified as FDA Class II. The hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Sentara Enterprises is recalling specific lots of CUBICIN (daptomycin) in NS, packaged in various syringe and homepump sizes. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected lots were compounded between September 11, 2015, and September 17, 2015. The products were distributed in Virginia and North Carolina. The recall includes multiple concentrations and packaging formats, including syringes and homepumps.
Healthcare providers and patients should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML…
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic
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 (13)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 24-Sep-15
- b) 24-Sep-15
- 27-Sep-15
- c) 26-Sep-15
- d) 24-Sep-15
- e) 27-Sep-15
- f) 26-Sep-15
- 27-Sept-15
- g) 24-Sep-15
- h) 26-Sep-15
- i) 27-Sep-15
- j) 26-Sep-15
- k) 21-Sep-15 l) 24-Sep-15
Distribution
Part of a larger recall action
This product is one of 34 recalled by Sentara Enterprises 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.
See all 34 products in this recall →Related recalls
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