Sentara Recalls Cefepime Homepumps Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of Cefepime Homepumps because the sterility of the product cannot be guaranteed.
What this means for you
Illness, injury, or structural failure has been reported. 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 failure in a drug) are categorized as Severe.
Plain-English summary
Sentara Enterprises is recalling specific lots of Cefepime packaged in Homepumps. The recall involves three product configurations: 1GM in 50ML, 2GM in 100ML, and 12GM in 600ML. The affected units were compounded between September 11, 2015, and September 17, 2015, and were distributed in Virginia and North Carolina.
The reason for the recall is a lack of assurance of sterility. The manufacturer states that the sterility of the product cannot be guaranteed. This is a Class II recall, 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 lots immediately. Patients should contact their healthcare provider for alternative treatment options. The recall is limited to the specific lots and dates identified in the source information.
The recalled product
- Product
- CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM 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
- Hazard
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 (4)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15
- b) 30-Sep-15
- 1-Oct-15
- c) 28-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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