Sentara Recalls Ceftriaxone Infusions Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Ceftriaxone in NS Homepumps because product sterility cannot be guaranteed. The recall affects 82 bags distributed in Virginia and North Carolina.
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 and involves a lack of assurance of sterility, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Sentara Enterprises is recalling specific lots of Ceftriaxone in NS, packaged as Homepumps, due to a lack of assurance of sterility. The affected products are prescription-only and were compounded between September 11, 2015, and September 17, 2015. The recall includes 8 bags of 1GM in 50ML, 70 bags of 2GM in 100ML, and 4 bags of 8GM in 200ML.
The recall was initiated because the sterility of the product cannot be guaranteed. The affected lots were distributed in the United States, specifically in Virginia and North Carolina. The expiration dates for the recalled products range from September 21, 2015, to September 27, 2015.
Consumers and healthcare providers should stop using the affected products immediately. Patients who have received these infusions should contact their healthcare provider for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic Infusion
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 (7)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15
- 27-Sep-15
- b) 21-Sep-15
- 24-Sep-15
- 25-Sep-15
- 26-Sep-15
- c) 25-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.
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