Sentara Recalls AZACTAM Bags Due to Sterility Assurance Concerns
Sentara Enterprises is recalling 12 bags of AZACTAM (aztreonam) 2GM in NS because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
Sentara Enterprises is recalling 12 bags of AZACTAM (aztreonam) 2GM in NS, packaged in 100ML Homepumps, due to a lack of assurance of sterility. The product is prescription-only and was distributed in the United States, specifically in Virginia and North Carolina.
The recall covers all lots compounded between September 11, 2015, and September 17, 2015, with an expiration date of September 30, 2015. The recall was initiated because the sterility of the product cannot be guaranteed.
Patients who have received this medication should contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML 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
- 12
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: 30-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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