FDA recall D-0300-2021

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.

Distribution

GA

Key facts

Status

Terminated

Initiation date

2021-03-02

Report date

2021-03-24

Termination date

2021-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0300-2021