Drug product
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
D-0309-2015
Product summary
- Event
- Event 69633
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0309-2015
Official wording
Reason: 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.
Code information: Lot #: 071714A
Distribution pattern: KY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility