Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN
Reported: September 23, 2015 Initiated: June 2, 2015 #D-1483-2015
Product Description
Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Details
- Recalling Firm
- The Compounding Pharmacy of America
- Units Affected
- 66 ml total volume
- Distribution
- Nationwide
- Location
- Knoxville, TN
Frequently Asked Questions
What product was recalled? ▼
Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN. Recalled by The Compounding Pharmacy of America. Units affected: 66 ml total volume.
Why was this product recalled? ▼
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 23, 2015. Severity: Moderate. Recall number: D-1483-2015.
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