D-0309-2015 Class II Terminated
FDA drug recall D-0309-2015 was initiated by Vann Healthcare Services Inc on October 14, 2014 and is designated Class II. 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 … The recall status is terminated (terminated July 1, 2015). Affected quantity: 1 vial.
Recall Details
- Product Type
- Drugs
- Report Date
- December 31, 2014
- Initiation Date
- October 14, 2014
- Termination Date
- July 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 vial
Product Description
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
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.
Distribution Pattern
KY
Code Information
Lot #: 071714A