Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-805 Supply Disruption — American Pharmaceutical Ingre
Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-805 Supply Disruption — American Pharmaceutical Ingre is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-805; Manufacturer: Ameri
| Drug name | Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-805 |
|---|---|
| Manufacturer | American Pharmaceutical Ingredients LLC |
| Recall/Disruption reason | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0499-2018 |
| Initiation date | 20180209 |
| Quantity affected | 4600 g |
| Dosage form | Drugs |
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