Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bo Supply Disruption — AuroMedics Pharma LLC (Modera
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bo Supply Disruption — AuroMedics Pharma LLC (Modera is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bo; Manufacturer: AuroM
| Drug name | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bo |
|---|---|
| Manufacturer | AuroMedics Pharma LLC |
| Recall/Disruption reason | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0529-2020 |
| Initiation date | 20191106 |
| Quantity affected | 19320 bottles |
| Dosage form | Drugs |
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