Class II
Terminated
All sterile products within expiry
This recall has been terminated (originally issued October 15, 2014).
- Company
- Unique Pharmaceutical, Ltd
- Recall Initiated
- July 18, 2014
- Posted
- October 15, 2014
- Recall Number
- D-0012-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 325,225 units (syringes, vials, bags)
- Firm Location
- Temple, TX, United States
- Official Source
- View on FDA website ↗
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
Nationwide
Lot / Code Info
All Lots
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