Skip to content
Recall Observatory FDA recall evidence

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

October 14, 2014

Class II

Product summary

Firm
Vann Healthcare Services Inc
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility