Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-3 Supply Disruption — Aurobindo Pharma USA Inc (Mod
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-3 Supply Disruption — Aurobindo Pharma USA Inc (Mod is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-3; Manufacturer: Aurob
| Drug name | Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-3 |
|---|---|
| Manufacturer | Aurobindo Pharma USA Inc |
| Recall/Disruption reason | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0077-2025 |
| Initiation date | 20241107 |
| Quantity affected | 102576 bottles |
| Dosage form | Drugs |
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