Recalls / Class II
Class IID-1751-2015
Product
Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 03022015@60, 8/29/2015; 12042014@65, 6/2/2015; 12182014@39, 6/16/2015; 01152015@37, 7/14/2015; 01052015@1, 7/4/2015; 02052015@50, 8/4/2015; 02132015@14, 8/12/2015; 03162015@14, 9/12/2015; 03252015@14, 9/21/2015; 04222015@44, 10/19/2015, 05042015@28, 10/31/2015
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recalling firm
- Firm
- The Compounding Pharmacy of America
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6216 Highland Place Way Ste 101-A, Knoxville, Tennessee 37919-4068
Distribution
- Quantity
- 265 pellets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-02
- FDA classified
- 2015-09-15
- Posted by FDA
- 2015-09-23
- Terminated
- 2016-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1751-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.