Reported Dec 31, 2014 · Terminated
Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx,…
Vann Healthcare Services Inc.
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: Vann Healthcare Services Inc · 1220 N Race St · Glasgow, KY · 42141-3462
Is this the product you have?
Tri-mix #4 (Papaverine 30 mgPhentolamine 1 mgProstaglandin-1 10 mcg/mL)packaged in 10 mL sterile glass vialsRxVann Healthcare Pharmacy1220 N Race StreetGlasgowKY 42141
- Lot codes and dates
- Lot #s: 04302014@1; 5 mL vial 05072014@4; 10 mL vial 05212014@2; 10 mL vial 06192014@2; 10 mL vial 08072014@4; 5 mL vial 10022014@4; 10 mL split into 2 - 5 mL vials for two different patients
- Amount recalled
- 7 vials
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
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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