Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Supply Disruption — THE COMPOUNDING SHOP, INC. (M
Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Supply Disruption — THE COMPOUNDING SHOP, INC. (M is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding; Manufacturer: THE C
| Drug name | Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding |
|---|---|
| Manufacturer | THE COMPOUNDING SHOP, INC. |
| Recall/Disruption reason | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-565-2013 |
| Initiation date | 20130502 |
| Quantity affected | 32 vials of 50mL |
| Dosage form | Drugs |
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