Recalls / Class II
Class IID-1696-2015
Product
MEGA-BURN 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; 04212015@10, 7/20/2015; 02232015@86, 5/24/2015; 02252015@79, 5/26/2015; 03112015@21, 6/9/2015; 03232015@40, 6/21/2015; 03242015@76, 6/22/2015; 03312015@60, 6/29/2015; 03272015@27, 6/25/2015; 04022015@62, 7/1/2015; 04072015@55, 7/6/2015; 04142015@59, 7/13/2015; 04212015@30, 7/20/2015; 04212015@54, 7/20/2015; 04222015@31, 7/21/2015; 05042015@64, 8/2/2015; 05052015@60, 8/3/2015; 04272015@77, 7/26/2015; 04292015@14, 7/28/2015; 04292015@23, 7/28/2015; 05052015@92, 8/3/2015; 05082015@23, 8/6/2015; 05012015@11, 7/30/2015; 05052015@98, 8/3/2015
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
- 3513 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-1696-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.