Recalls / Class II
Class IID-1742-2015
Product
Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 01082015@1, 7/7/2015; 11212014@6, 5/20/2015; 11212014@8, 5/20/2015; 1242014@51, 5/23/2015, 11262014@72, 5/25/2015, 01152015@29, 7/14/2015; 02112015@12, 8/10/2015; 12192014@6, 6/17/2015; 12012014@57, 5/30/2015; 12022014@33; 5/31/2015; 12042014@50, 6/2/2015; 12152014@10, 6/13/2015; 12082014@38; 6/6/2015; 12182014@18, 6/16/2015; 12092014@62, 6/7/2015; 12292014@37, 6/27/2015; 12292014@72, 6/29/2015; 01222015@44, 7/21/2015; 01052015@3, 7/4/2015; 01092015@9, 7/8/2015; 01202015@42; 7/19/2015; 04212015@11, 10/18/2015; 01272015@40, 7/26/2015; 01292015@25, 7/28/2015; 01282015@30, 7/27/2015; 02102015@34, 8/9/2015; 02092015@29, 8/8/2015; 02132015@26, 8/12/2015; 02232015@10, 8/22/2015; 02242015@13, 8/23/2015; 02162015@28, 8/15/2015; 04102015@38, 10/7/2015; 05042015@34, 10/31/2015; 02272015@29, 8/26/2015, 03032015@16, 8/30/2015, 03112015@34, 9/7/2015; 03182015@26, 9/14/2015; 03272015@29; 9/23/2015; 04012015@5, 9/28/2015, 04062015@16, 10/3/2015; 04032015@57, 9/30/2015; 04212015@42; 10/18/2015; 05012015@6, 10/28/2015; 05072015@57, 11/3/2015; 05042015@13, 10/31/2015; 04272015@39, 10/24/2015, 04282015@60, 10/25/2015; 05062015@14, 11/2/2015; 05112015@28, 11/7/2015
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
- 1222 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-1742-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.