Recalls / Class II
Class IID-1444-2015
Product
B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 02192015@21, 5/20/2015; 03032015@3, 6/1/2015; 02242015@37, 5/25/2015; 03122015@27, 6/10/2015; 03182015@48, 6/16/2015; 03272015@14, 6/25/2015; 04072015@16, 7/6/2015, 04072015@18, 7/6/2015, 04202015@80, 7/19/2015, 04222015@85, 7/21/2015; 05072015@25, 8/5/2015; 04272015@74, 7/26/2015; 04272015@81, 7/26/2015; 04292015@98, 7/28/2015; 05012015@17, 7/30/2015; 05042015@45, 8/2/2015; 02202015@47, 5/21/2015
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
- 1397 mL total volume
- 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-1444-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.