Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, Supply Disruption — THE COMPOUNDING SHOP, INC. (Mo
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, Supply Disruption — THE COMPOUNDING SHOP, INC. (Mo is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop,; Manufacturer: THE CO
| Drug name | Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, |
|---|---|
| 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-550-2013 |
| Initiation date | 20130502 |
| Quantity affected | 1 vial of 22mL |
| Dosage form | Drugs |
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