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 Distr
Recalled October 14, 2020 · FDA recall D-0016-2021 · Direct Rx
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product. · FDA Class II
Units
a) 54 bottles; b) 26 bottles
Sold at
FL, GA
Description
CGMP Deviations: Presence of NDMA impurity detected in product.
Product
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
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →