FDA-Drug2020-10-14Class II
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
Direct Rx
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
Sold states
FL, GA
Affected count
a) 54 bottles; b) 26 bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0016-2021Don't want to check this manually?
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