D-0012-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2014
- Initiation Date
- July 18, 2014
- Termination Date
- February 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 325,225 units (syringes, vials, bags)
Product Description
All sterile products within expiry
Reason for Recall
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Distribution Pattern
Nationwide
Code Information
All Lots