Class II
Terminated
All Sterile Products within expiry
This recall has been terminated (originally issued December 27, 2017).
- Recall Initiated
- August 17, 2017
- Posted
- December 27, 2017
- Recall Number
- D-0148-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 61 Products
- Firm Location
- Pompano Beach, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility .
Distribution
Nationwide.
Lot / Code Info
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products
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