Reported Feb 3, 2016 · Terminated
VANCOMYCIN HCL, Packaged as
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?
VANCOMYCIN HCL, Packaged as
13 of 13 products
| # | Product as published |
|---|---|
| 1 | 600MG in 120ML Homepumps |
| 2 | 750MG in 150ML Homepumps |
| 3 | 850MG in 170ML Homepumps |
| 4 | 1GM in 200ML Homepumps |
| 5 | 1.25GM in 250ML Homepumps |
| 6 | 1.5GM in 300ML Homepumps |
| 7 | 1.75GM in 350ML Homepumps |
| 8 | 2GM in 400ML Homepumps |
| 9 | 4000MG in 800ML Homepumps |
| 10 | 5000MG in 1000ML Homepumps |
| 11 | 6GM in 1200ML Homepumps |
| 12 | 7.5GM in 1500ML Homepumps, and |
| 13 | 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. |
- Lot codes and dates
13 of 13 products
Products covered by this recall # Product as published 1 29-Sep-15, 30-Sep-15 2 25-Sep-15, 29-Sep-15 3 25-Sep-15 4 25-Sep-15, 26-Sep-15, 29-Sep-15 5 25-Sep-15, 1-Oct-15 6 28-Sep-15, 29-Sep-15, 1-Oct-15 7 25-Sep-15 8 25-Sep-15, 27-Sep-15, 29-Sep-15 9 29-Sep-15 10 25-Sep-15, 26-Sep-15 11 29-Sep-15 12 25-Sep-15, 27-Sep-15, 30-Sep-15 13 1-Oct-15 - Amount recalled
- a) 12 Bags, b) 36 Bags, c) 8 Bags, d) 65 Bags, e) 18 Bags, f) 36 Bags g) 21 Bags, h) 7 Bags, i) 3 Bags, j) 3 Bags, k) 2 Bags, l) 6 Bags, m) 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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