FDANovember 13, 2019drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.

What to do

FDA enforcement status: Terminated

Brands named

precision doseprecision

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear