Recalls / Class II
Class IID-1699-2015
Product
MEGA-BURN III 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; 03022015@28, 5/31/2015; 04152015@17, 7/14/2015; 04152015@44, 7/14/2015; 02272015@62, 5/28/2015; 03032015@25, 6/1/2015; 03122015@89, 6/10/2015; 03162015@58, 6/14/2015; 03182015@28, 6/16/2015; 03302015@26, 6/28/2015; 04062015@65, 7/5/2015; 04142015@45, 7/13/2015; 04172015@46, 7/16/2015; 04242015@27, 7/23/2015; 04292015@31, 7/28/2015; 04292015@81, 7/28/2015; 5082015@63, 8/6/2015; 04302015@9, 7/29/2015; 05112015@30, 8/9/2015; 5072015@14, 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
- 1436 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-1699-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.