Recalls / Class II
Class IID-1464-2015
Product
Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 12082014@56, 6/6/2015; 01222015@28, 7/21/2015; 01062015@73, 7/5/2015; 03022015@55, 8/29/2015; 03242015@94, 9/20/2015; 04222015@32, 10/19/2015; 04222015@47, 10/19/2015; 04222015@49, 10/19/2015; 04302015@54, 10/27/2015
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
- 212 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-1464-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.