Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Pre Supply Disruption — The Compounding Pharmacy of A
Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Pre Supply Disruption — The Compounding Pharmacy of A is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Pre; Manufacturer: The C
| Drug name | Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Pre |
|---|---|
| Manufacturer | The Compounding Pharmacy of America |
| Recall/Disruption reason | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and steri |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1492-2015 |
| Initiation date | 20150602 |
| Quantity affected | 43 ml total volume |
| Dosage form | Drugs |
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