THE COMPOUNDING SHOP, INC. Recall: Phosphatidyl Choline 10%, Injectable, 500 mL vial, comp
THE COMPOUNDING SHOP, INC. Recall: Phosphatidyl Choline 10%, Injectable, 500 mL vial, comp is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: THE COMPOUNDING SHOP, INC.; Product: Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL; Rea
| Recalling firm | THE COMPOUNDING SHOP, INC. |
|---|---|
| Product | Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL |
| Reason for recall | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Florida, California, Minnesota, and Maine |
| Recall initiated | 20130502 |
| Recall number | D-565-2013 |
| Category | drug |
| State | FL |
| Country | United States |
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