Recalls / Class II
Class IID-1638-2015
Product
Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Affected lot / code info
- All lots distributed between November 2014 and May 2015; 04212015@27, 6/2062015; 02272015@42, 5/28/2015; 03112015@3, 6/9/2015; 03162015@85, 6/14/2015; 03242015@3, 6/22/2015; 03302015@63, 6/28/2015, 04062015@44, 7/5/2015; 04142015@63, 7/13/2015; 04212015@28, 6/20/2015; and 05072015@8, 7/6/2015,
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
- 200 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-1638-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.