FDA Drug Class II — Moderate

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

Hazard

CGMP Deviations: Presence of NDMA impurity detected in product.

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Products

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
Brand
Direct Rx
UPC
Lots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022

Units Affected

a) 54 bottles; b) 26 bottles

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