Vann Healthcare Services Inc: 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.

Agency Publication Date: December 19, 2014

Affected Products

Product: Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Lot #: 071714A

Lot Numbers:

071714A

Product: Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Lot #s: 06094A, 06254A, 07164A, 08114A, and 08284C.

Product: Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Lot #s: 06174A, 07214B, and 08154A.

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

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69633

Status: Resolved

Manufacturer: Vann Healthcare Services Inc

Manufactured In: United States

Units Affected: 4 products (1 vial; 410 syringes; 900 syringes; 7 vials)

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Sources: FDA iRES · Raw API Response

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