Recalls / Class II
Class IID-1642-2015
Product
Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 01142015@3, 7/13/2015; 01142015@13, 7/13/2015; 03032015@47, 8/30/2015; 05042015@33, 10/31/2015; 11242014@30, 5/23/2015; 11242014@34, 5/23/2015; 12182014@79, 6/16/2015; 12232014@4, 6/21/2015; 01232015@28, 7/22/2015; 01142015@17, 7/13/2015; 01302015@6, 7/29/2015; 02022015@5, 8/1/2015; 04092015@10, 10/6/2015; 02162015@4, 8/15/2015; 02192015@19, 8/18/2015; 03032015@48, 8/30/2015; 03202015@100, 9/16/2015; 03202015@11, 9/16/2015; 04132015@18, 10/10/2015; 04202015@14, 10/17/2015; 03302015@12, 9/26/2015; 04062015@23, 10/3/2015; 04082015@10, 10/5/2015; 04242015@1, 10/21/2015; 04292015@29, 10/26/2015; 12012014@23, 5/30/2015; 03042015@50, 8/31/2015; 03262015@56, 9/22/2015; 04062015@21, 10/3/2015; 05012015@51, 10/28/2015; 11242014@8, 5/23/2015; 05052015@23, 11/1/2015; 12042014@54, 6/2/2015; 04102015@21, 10/7/2015; 01122015@41, 7/11/2015; 12162014@3, 6/14/2015; 12012014@28, 5/30/2015; 12052014@17, 6/3/2015; 12172014@34, 6/15/2015; 12192014@51, 6/17/2015; 01072015@7, 7/6/2015; 01182015@6, 7/17/2015; 01192015@4, 7/18/2015; 01232015@25, 7/22/2015; 01072015@61, 7/6/2015; 01192015@37, 7/18/2015; 01062015@3, 7/5/2015; 01302015@58, 7/29/2015; 01272015@22, 7/26/2015; 02022015@9, 8/1/2015; 02062015@1, 8/5/2015; 02102015@49, 8/9/2015; 02052015@37, 8/4/2015; 02052015@62, 8/4/2015; 02052015@71, 8/4/2015; 02062015@25, 8/5/2015; 02092015@66, 8/8/2015; 05072015@41, 11/3/2015; 02132015@2, 8/12/2015; 02232015@57, 8/22/2015; 02242015@16, 8/23/2015; 02192015@42, 8/18/2015; 04082015@26, 10/5/2015; 02272015@67, 8/26/2015; 03022015@75, 8/29/2015; 04082015@30, 10/5/2015; 03102015@2, 9/6/2015; 03032015@53, 8/30/2015; 03032015@55, 8/30/2015; 03062015@11, 9/2/2015; 03062015@31, 9/2/2015; 03192015@45, 9/15/2015; 03252015@47, 9/21/2015; 03272015@53, 9/23/2015; 04022015@1, 9/29/2015; 04022015@6, 9/29/2015; 04012015@75, 9/28/2015; 04202015@57, 10/17/2015; 04202015@61, 10/17/2015; 04212015@40, 10/18/2015; 04242015@9, 10/21/2015; 04282015@43, 10/25/2015; and 05052015@21, 11/1/2015
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
- 9026 ml
- 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-1642-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.