Precision Dose Inc. Recall: Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit
Precision Dose Inc. Recall: Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Precision Dose Inc.; Product: Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit
| Recalling firm | Precision Dose Inc. |
|---|---|
| Product | Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080 |
| Reason for recall | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide USA |
| Recall initiated | 20191113 |
| Recall number | D-1004-2020 |
| Category | drug |
| State | IL |
| Country | United States |
$29/mo
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