FDA-Drug2021-03-24Class II
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Direct Rx
Hazard
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Sold states
GA
Affected count
17 bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
Products
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0300-2021Don't want to check this manually?
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