Precision Dose Inc. recalls 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 Do
Recalled March 18, 2020 · FDA recall D-1004-2020 · Precision Dose
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. · FDA Class II
Units
224,940 unit dose cups
Sold at
Nationwide USA
Description
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
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
Manufacturer(s)
Precision Dose Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →