Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Reported: September 23, 2015 Initiated: June 2, 2015 #D-1677-2015
Product Description
Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, 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
- 45 ml
- Distribution
- Nationwide
- Location
- Knoxville, TN
Frequently Asked Questions
What product was recalled? ▼
Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN. Recalled by The Compounding Pharmacy of America. Units affected: 45 ml.
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-1677-2015.
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