Ranitidine 150 mg recalled over manufacturing violations

Recall date

January 15, 2020

Source

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

Official notice title

Direct Rx recalls Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Dist…

Recall number

D-0016-2021

FDA classification

Class II

Brand / firm

Direct Rx

Sold / distributed

FL, GA

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

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 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534