Direct Rx: Drug Recall

Recall #D-0300-2021 · 03/02/2021

Class II: Risk

Recall Details

Recall Number
D-0300-2021
Classification
Class II
Product Type
Drug
Recalling Firm
Direct Rx
Status
Terminated
Date Initiated
03/02/2021
Location
Dawsonville, GA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 bottles

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.

Product Description

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

Distribution Pattern

GA

Other Recalls by Direct Rx

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.