Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case Supply Disruption — Precision Dose Inc. (Moderate
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case Supply Disruption — Precision Dose Inc. (Moderate is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case; Manufacturer: Preci
| Drug name | Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case |
|---|---|
| Manufacturer | Precision Dose Inc. |
| Recall/Disruption reason | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1004-2020 |
| Initiation date | 20191113 |
| Quantity affected | 224,940 unit dose cups |
| Dosage form | Drugs |
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