Drug 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
D-0312-2015
Product summary
- Event
- Event 69633
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 vials
- Official record key
drug-enforcement:D-0312-2015
Official wording
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.
Code information: 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
Distribution pattern: KY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility