Sentara Recalls Ampicillin/Sulbactam Bags Due to Sterility Concerns
Sentara Enterprises is recalling 9 bags of Ampicillin/Sulbactam 12GM in NS due to a lack of assurance of sterility. The affected products 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, which corresponds to a Severe severity score according to the rubric for significant injury or property damage reports, or in this case, a significant risk of harm due to lack of sterility assurance.
Plain-English summary
Sentara Enterprises is recalling 9 bags of Ampicillin/Sulbactam 12GM in NS, packaged in 600ML Homepumps. The product is prescription-only and was distributed in the United States, specifically in Virginia and North Carolina.
The recall was initiated because the product sterility cannot be guaranteed. The affected lots were compounded between September 11, 2015, and September 17, 2015, with expiration dates of September 17, 2015, and September 19, 2015.
Consumers and healthcare providers should stop using the affected product immediately and contact their healthcare provider or Sentara Enterprises for further instructions.
The recalled product
- Product
- Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antibiotic
- Affected units
- 9
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)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 17-Sep-15
- 19-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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