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.
Recall initiated: 20191113
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated