Product: Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
Reason for recall: 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.
Recall initiated: 20210302
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated