Class II
Terminated
Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
This recall has been terminated (originally issued September 23, 2015).
- Recall Initiated
- June 2, 2015
- Posted
- September 23, 2015
- Recall Number
- D-1664-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 112 ml
- Firm Location
- Knoxville, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Distribution
Nationwide
Lot / Code Info
All lots distributed between November 2014 and May 2015; 02112015@40, 8/10/2015; 03132015@26, 7/20/2015; 04012015@11, 9/28/2015; 04272015@51, 10/24/2015
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