Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
KY
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0312-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 14, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 7 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vann Healthcare Services Inc
Original FDA data
Every field from FDA enforcement report D-0312-2015, exactly as published.
Show all FDA fields
- City
- Glasgow
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 69633
- Address
- 1220 N Race St
- 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
- Postal code
- 42141-3462
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0312-2015
- Classification
- Class II
- Recalling firm
- Vann Healthcare Services Inc
- Product quantity
- 7 vials
- Termination date
- Jul 1, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- KY
- Recall initiation date
- Oct 14, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 19, 2014