D-0012-2015 Class II Terminated
FDA drug recall D-0012-2015 was initiated by Unique Pharmaceutical, Ltd on July 18, 2014 and is designated Class II. 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. The recall status is terminated (terminated February 24, 2016). Affected quantity: 325,225 units (syringes, vials, bags).
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