Recalls / Class II
Class IID-1616-2015
Product
Nandrolone Decanoate 200 mg/ml Injection, ml 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: 02272015@1, 8/26/2015; 12182015@67, 6/16/2015; 02062015@141, 8/5/2015; 04222015@13, 9/29/2015; 04072015@33, 10/4/2015; 04212015@13, 10/18/2015; 04082015@7, 10/5/2015 ; 04142015@24, 10/11/2015; 04272015@84, 10/24/2015; and 05082015@7, 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
- 169 ml total volume
- 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-1616-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.