Sentara Recalls Ganciclovir Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Ganciclovir in NS Homepumps because product sterility cannot be guaranteed. The affected products 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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility issues in injectable products where hospitalization or significant injury is a potential risk.
Plain-English summary
Sentara Enterprises is recalling Ganciclovir in NS, packaged as 320MG in 64ML Homepumps and 2440MG in 488ML Homepumps. The recall is due to a lack of assurance of sterility, meaning the product sterility cannot be guaranteed. The affected lots were compounded between September 11, 2015, and September 17, 2015, with expiration dates ranging from September 25, 2015, to October 1, 2015.
The recall involves 22 bags of the 320MG/64ML formulation and 3 bags of the 2440MG/488ML formulation. These prescription-only products were distributed in the United States, specifically in Virginia and North Carolina. The products were manufactured by Sentara Enterprises and distributed by Sentara Home Health Sentara RX in Chesapeake, Virginia.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions. 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.
The recalled product
- Product
- GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Injectable Sterile
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 (3)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15
- 1-Oct-15
- b) 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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