D-0312-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 31, 2014
- Initiation Date
- October 14, 2014
- Termination Date
- July 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 vials
Product Description
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 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.
Distribution Pattern
KY
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