Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Tri-mix #4
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Drug: Papaverine
- Recalling firm
- Vann Healthcare Services Inc
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0312-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Papaverine recalls
See all
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Other recalls by Vann Healthcare Services Inc
All 2014 recalls
Class II · Moderate risk
Lidocaine 4% Syr
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.
Class II · Moderate risk
Epinephrine 1:1000
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.
Class II · Moderate risk
Hydroxyprogesterone Caproate
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.
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