Recalls / Class II
Class IID-1766-2015
Product
Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12192014@10, 6/17/2015; 12022014@4, 5/31/2015; 12302014@56, 6/28/2015; 01262015@84, 7/25/2015, 03302015@51, 9/26/2015; 05052015@83, 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
- 62 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-1766-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.