Reported Feb 3, 2016 · Terminated
GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME…
Sentara Enterprises
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sentara Enterprises · 535 Independence Pkwy Ste 300 · Chesapeake, VA · 23320-5176
Is this the product you have?
- 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.
- Lot codes and dates
- All Lots compounded between 11-Sep-15 and 17-Sep-15
- Expiries
a) 25-Sep-151-Oct-15b) 28-Sep-15
- Amount recalled
- a) 22 Bags, b) 3 Bags
This recall covers 34 products
The agency filed one notice per product. You are reading one of them; the other 33 are below.
21 more are in the archive.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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