Recalls / Class II
Class IID-1651-2015
Product
Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 12032014@47, 6/1/2015; 12052014@36, 6/3/2015; 12192014@33, 6/17/2015; 01202015@53, 7/19/2015; 01062015@58, 7/5/2015; 02122015@40, 8/11/2015; 03022015@15, 8/29/2015; 03252015@22, 9/21/2015; 05082015@6, 11/4/2015
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
- 216 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-1651-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.