Recalls / Class II
Class IID-1723-2015
Product
Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 04102015@70, 7/9/2015; 04212015@9, 7/20/2015; 04092015@75, 7/8/2015; 03022015@1, 5/31/2015; 04202015@12, 7/19/2015; 03112015@19, 6/9/2015; 03032015@36, 6/1/2015; 03032015@40, 6/1/2015; 03062015@28, 6/4/2015; 03192015@5, 6/17/2015; 03202015@15, 6/18/2015; 03172015@18, 6/15/2015; 03172015@27, 7/13/2015; 03202015@87, 6/18/2015; 03242015@35, 6/22/2015; 05042015@76, 8/2/2015; 03272015@9, 6/25/2015; 03312015@14, 6/29/2015; 03272015@33, 6/25/2015; 03272015@43, 6/25/2015; 04012015@37, 6/30/2015; 04022015@32, 7/1/2015; 04162015@39, 7/15/2015; 04232015@5, 7/22/2015; 04212015@65, 7/20/2015; 04222015@48, 7/21/2015; 04272015@65, 7/26/2015; 05052015@96, 8/3/2015; 05012015@34, 7/30/2015; 05052015@87, 8/3/2015; 05072015@53, 8/5/2015
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
- 3215 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-1723-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.