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
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Lot numbers, UPCs & expiration codes
Lot #: 071714A
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-0309-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 14, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 1 vial
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vann Healthcare Services Inc
Original FDA data
Every field from FDA enforcement report D-0309-2015, 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 #: 071714A
- Postal code
- 42141-3462
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0309-2015
- Classification
- Class II
- Recalling firm
- Vann Healthcare Services Inc
- Product quantity
- 1 vial
- 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
- Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, 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