drugs Class II Updated 2014-12-31

Vann Healthcare Services Inc recalls Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostagland

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: KY
Lot/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 mL vial 10022014@4; 10 mL split into 2 - 5 mL vials for two different patients
View official government recall

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