Recalls / Class II
Class IID-1776-2015
Product
Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 01302015@29, 7/29/2015; 04162015@31, 10/13/2015, 12162014@27, 6/14/2015; 01192015@8, 7/18/2015; 01142015@29, 7/13/2015; 01262015@49, 7/25/2015; 01092015@32, 7/8/2015; 01292015@37, 7/28/2015, 02112015@30, 8/10/2015; 02262015@5, 8/25/2015; 02272015@73, 8/26/2015; 03032015@18, 8/30/2015; 03062015@32, 9/2/2015; 03192015@44, 9/15/2015; 03302015@15, 9/26/2015; 04082015@8, 10/5/2015; 04062015@49, 10/3/2015; 04222015@81, 10/19/2015; 04302015@36, 10/27/2015; 05052015@41, 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
- 139 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-1776-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.