Reported Oct 15, 2014 · Terminated
All sterile products within expiry
Unique Pharmaceutical, Ltd.
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: Unique Pharmaceutical, Ltd · 5920 S General Bruce Dr · Temple, TX · 76502-5803
Is this the product you have?
- All sterile products within expiry
- Lot codes and dates
- All Lots
- Amount recalled
- 325,225 units (syringes, vials, bags)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
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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