Sentara Recalls Ondansetron HCL 8mg Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling 77 bags of Ondansetron HCL 8mg Homepumps because the product's sterility cannot be guaranteed. The affected lots were distributed in Virginia and North Carolina.
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 issues in injectable/infusion products) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited but the risk is significant.
Plain-English summary
Sentara Enterprises is recalling 77 bags of Ondansetron HCL 8mg, packaged in 100ml Homepumps, due to a lack of assurance of sterility. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
The recall includes all lots compounded between September 11, 2015, and September 17, 2015. The expiration dates for these products are September 25, 2015, September 28, 2015, September 29, 2015, and October 1, 2015. The affected products were distributed in the United States, specifically in Virginia and North Carolina.
Consumers and healthcare providers should stop using the recalled products immediately and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- ONDANSETRON HCL 8MG, 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 — Compounded Medication
- Affected units
- 77
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: 25-Sep-15
- 28-Sep-15
- 29-Sep-15
- 1-Oct-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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