CLASS II Drug recall · Reported 31 Dec 2014 · FDA Enforcement Report
Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg recalled
Vann Healthcare Services is recalling Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), distributed in Kentucky. The recall was initiated on 14 Oct 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0312-2015
- FDA event ID
- 69633
- Recalling firm
- Vann Healthcare Services, Glasgow, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Oct 2014
- FDA classified
- 19 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Oct 2014 | Recall initiated by company | |
| 19 Dec 2014 | Classified by FDA | +66 days |
| 31 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
KY
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
KY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 69633More recalls from Vann Healthcare Services
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann recalled | Vann Healthcare Services | Sterility | KY |
| Drug | CLASS II | Lidocaine 4% Syr (PF) Rx recalled by Vann Healthcare Services | Vann Healthcare Services | Sterility | KY |
| Drug | CLASS II | Hydroxyprogesterone Caproate, 250 mg per mL vial, Rx recalled | Vann Healthcare Services | Sterility | KY |