Sentara Recalls Nafcillin Bags Due to Sterility Assurance Concerns
Sentara Enterprises is recalling 28 bags of Nafcillin 2GM in NS due to a lack of assurance of sterility. The affected product was 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are rated as Severe (4), as they are not Class I but involve significant risk.
Plain-English summary
Sentara Enterprises is recalling 28 bags of Nafcillin 2GM in NS, packaged in 50ML Homepumps, due to a lack of assurance of sterility. The product is prescription-only and was compounded by Sentara Home Health Sentara RX in Chesapeake, Virginia.
The recall covers all lots compounded between September 11, 2015, and September 17, 2015, with an expiration date of September 27, 2015. The affected product was distributed in the United States, specifically in Virginia and North Carolina.
The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 28
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: 27-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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