Ranitidine Oral Solution recalled over manufacturing violations

Recall date

November 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 D…

Recall number

D-1004-2020

FDA classification

Class II

Brand / firm

Precision Dose Inc.

Sold / distributed

Nationwide USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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