FDAJanuary 15, 2020drug

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

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

The hazard

CGMP Deviations: Presence of NDMA impurity detected in product.

What to do

FDA enforcement status: Terminated

Brands named

direct rxdirect

Recall history

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

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