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Recall Observatory FDA recall evidence

Drug product

Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330

D-0300-2021

March 02, 2021

Class II

Product summary

Firm
Direct Rx
Event
Event 87458
Status
Terminated
Classification
Class II
Quantity
17 bottles
Official record key
drug-enforcement:D-0300-2021

Official wording

Reason: 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.

Code information: Lot#: 28DE2002 Exp 10/31/22

Distribution pattern: GA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations