FDA Drug recall D-0312-2015
Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pha…
- FDA Drug
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pha… by Vann Healthcare Services, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0312-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-14 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vann Healthcare Services |
| Distribution | KY |
Product
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
Reason
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.
Identifiers
| code_info | 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…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0312-2015%22
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