Sentara Recalls Fluconzole Bags Due to Sterility Assurance Issues
Sentara Enterprises is recalling 7 bags of Fluconzole in NaCl 400mg because product sterility cannot be guaranteed. The affected lots were 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 the rubric specifies that FDA Class II recalls with potential for significant injury (such as sterility issues in IV products) are rated as Severe.
Plain-English summary
Sentara Enterprises is recalling 7 bags of Fluconzole in NaCl 400mg packaged in 200ml Homepumps. The recall is being conducted because the product sterility cannot be guaranteed, presenting a lack of assurance of sterility.
The affected product is prescription-only and was compounded between September 11, 2015, and September 17, 2015, with an expiry date of September 25, 2015. Distribution was limited to the United States, specifically including Virginia and North Carolina.
Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or Sentara Enterprises for further instructions on disposal or replacement.
The recalled product
- Product
- FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — IV Infusion
- Affected units
- 7
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 (1)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 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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