Recalls / Class II
Class IID-1634-2015
Product
Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 04202015@78, 7/19/2015; 02242015@9, 5/25/2015; 03162015@75, 6/14/2015; 03312015@70, 6/29/2015; 04292015@87, 7/28/2015; 05042015@41, 8/2/2015; 04212015@16, 7/20/2015; 02242015@54, 5/25/2015; and 04222015@65, 7/21/2015
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
- 4554 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-1634-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.